510(k) K953640 ยท FAE Prosthesis, Penile
DUNA II PENILE PROSTHESIS
| Applicant | Dacomed Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 27, 1995 |
| Received | Aug 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2007 | American Medical Systems AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN Terminated |
FAE | None listed |
| Apr 3, 2007 | American Medical Systems AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN Terminated |
FAE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.