510(k) K982626 ยท EZL Catheter, Retention Type, Balloon
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
| Applicant | Medworks Corp., Pawtucket RI, US |
| Decision | Substantially Equivalent, Aug 20, 1998 |
| Received | Jul 28, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982626
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.