510(k) K082831 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
AMSELF CLOSED CATHETERIZATION SYSTEM
| Applicant | Amsino International, Inc., Pomona CA, US |
| Decision | Substantially Equivalent, Oct 23, 2008 |
| Received | Sep 26, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082831
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.