Data / Medical devices / United States / Aunt Flow Corp
Aunt Flow Corp: FDA-registered device maker in Columbus, OH, United States, 3 510(k) clearances
Aunt Flow Corp is registered with the FDA (registration 3015522042) in Columbus, OH, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 2, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015522042
- Address
- 757 Garden Road Ste 205, Columbus, OH, United States, 43214
- Owner or operator
- Aunt Flow Corp (10060629)
- Roles
- Repackager or relabeler
- First device listed
- June 4, 2019
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| November 2, 2018 | K181911 | Interlude 100% Cotton Tampon | HEB | Substantially Equivalent | Albaad Fem | accessdata.fda.gov |
| December 23, 2009 | K090819 | ONTEX TAMPON (UNSCENTED) | HEB | Substantially Equivalent | Ontex International NV | accessdata.fda.gov |
| August 3, 2000 | K001641 | TAMPONS | HEB | Substantially Equivalent | Rostam , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 2, 2018. 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.