510(k) K070939 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
| Applicant | Coloplast Manufacturing Us, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 1, 2007 |
| Received | Apr 4, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070939
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.