The following data is part of a premarket notification filed by Medworks Corp. with the FDA for Urethropexy Suture Placement Kit Model Numbers Um-300, Mw-100, Mini-laparotomy Mmk Kit Model Um-250, Laparoscopic Burch0.
| Device ID | K982626 |
| 510k Number | K982626 |
| Device Name: | URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | MEDWORKS CORP. 50 BREWSTER ST. Pawtucket, RI 02860 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau MEDWORKS CORP. 50 BREWSTER ST. Pawtucket, RI 02860 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-28 |
| Decision Date | 1998-08-20 |
| Summary: | summary |