Data / Medical devices / United States / Quest Products, Inc
Quest Products, Inc: FDA-registered device maker in Pleasant Prairie, WI, United States, 3 510(k) clearances
Quest Products, Inc is registered with the FDA (registration 3004087544) in Pleasant Prairie, WI, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004087544
- Address
- 8201 104th Street Suite 200, Pleasant Prairie, WI, United States, 53158
- Owner or operator
- Quest Products, Inc (9065117)
- Roles
- Repackager or relabeler
- First device listed
- January 7, 2014
- Registered through
- 2026
- Brand names listed
- Alocane Precision Freeze Skin Tag Remover, Dr Butler Holt/Cold Pack, Gengigel Gel; Gengigel Gel Junior; Gengigel Mouthrinse; Gengigel Professional Fluid; Gengigel Professional Gel; Gengigel, Quest Peak Flow Meter, breatheWELL, sleepWELL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Nasal | LWF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 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 |
|---|---|---|---|---|---|---|
| June 17, 2022 | K211099 | Freezen Clear Skin Clinic Warts & Tags | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| September 13, 2010 | K101380 | RXPEAKFLOW | BZH | Substantially Equivalent | Noble Marketing | accessdata.fda.gov |
| March 13, 2007 | K053342 | GENGIGEL MOUTHRINSE | OLR | Substantially Equivalent | Ricerfarma Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Dilator, Nasal
- All makers of Meter, Peak Flow, Spirometry
- All makers of Oral Wound Dressing
Updated June 17, 2022. 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.