510(k) K771650 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
AKRO-SIL FOLEY KIT 30CC
| Applicant | Latex Ind., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 20, 1977 |
| Received | Aug 29, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771650
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.