Data / Medical devices / United States / Metropolitan Graphic Arts, Inc.
Metropolitan Graphic Arts, Inc.: FDA-registered device maker in Gurnee, IL, United States, 7 510(k) clearances
Metropolitan Graphic Arts, Inc. is registered with the FDA (registration 3004402508) in Gurnee, IL, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004402508
- Address
- 3818 Grandville Ave, Gurnee, IL, United States, 60031
- Owner or operator
- Metropolitan Graphic Arts, Inc. (9099541)
- Roles
- Repackager or relabeler
- First device listed
- March 26, 2007
- Registered through
- 2026
- Brand names listed
- Bandage, Liquid, FOR INCONTINENCE, GARMENT, Garment, Protective, for Incontinence, MENSTRUAL, One By Poise, U by Kotex, Depend, Kotex, PAD, PADS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2023 | K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| November 2, 2011 | K113036 | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| December 23, 2009 | K091749 | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS | HEB | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| December 11, 2006 | K062602 | BAND-AID(R) BRAND LIQUID BANDAGE | KMF | Substantially Equivalent | Johnson & Johnson Consumer Companies, Inc. | accessdata.fda.gov |
| December 31, 1996 | K964016 | TIELLE HYDROPOLYMER FOAM DRESSING | KMF | Substantially Equivalent for Some Indications | Johnson & Johnson Medical, Inc. | accessdata.fda.gov |
| April 11, 1995 | K946245 | TIELLE* HYDROPOLYMER DRESSING | KMF | Substantially Equivalent | Johnson & Johnson International | accessdata.fda.gov |
| December 22, 1989 | K896994 | KOTEX SECURITY TAMPONS (SEVERAL TYPE) | HEB | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Unscented
- All makers of Bandage, Liquid
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
Updated January 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.