510(k) K913575 ยท FRO Dressing, Wound, Drug
GAUZE PACKING, SURGICAL STERILE AND NON-STERILE
| Applicant | Keilei Intl., Inc., Dover NJ, US |
| Decision | Substantially Equivalent, Sep 6, 1991 |
| Received | Aug 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913575
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.