The following data is part of a premarket notification filed by Medworks Corp. with the FDA for Medworks Visualization Insemination Catheter.
| Device ID | K982630 |
| 510k Number | K982630 |
| Device Name: | MEDWORKS VISUALIZATION INSEMINATION CATHETER |
| Classification | Cannula, Intrauterine Insemination |
| 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 | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-28 |
| Decision Date | 1999-01-14 |
| Summary: | summary |