Data / Medical devices / United States / Stephen Gould Corporation
Stephen Gould Corporation: FDA-registered device maker in Gahanna, OH, United States, 2 510(k) clearances
Stephen Gould Corporation is registered with the FDA (registration 3010167805) in Gahanna, OH, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 2, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010167805
- Address
- 861 Taylor Rd, Gahanna, OH, United States, 43230
- Owner or operator
- Stephen Gould Corporation (10087873)
- Roles
- Repackager or relabeler
- First device listed
- July 20, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
| 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.