510(k) K863213 ยท GDX Scalpel, One-Piece
KEISEI SCALPEL (STERILE AND NON-STERILE)
| Applicant | Keisei Medical Industrial Co., Ltd., Bethel CT, US |
| Decision | Substantially Equivalent, Sep 2, 1986 |
| Received | Aug 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863213
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.