510(k) K971228 ยท HEB Tampon, Menstrual, Unscented
FEMTEX 100% COTTON TAMPONS
| Applicant | Regu-Tech Assoc., Inc., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 9, 1997 |
| Received | Jan 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.