The following data is part of a premarket notification filed by Vesitec Medical, Inc. with the FDA for Vesitec Suture Passer.
| Device ID | K931181 |
| 510k Number | K931181 |
| Device Name: | VESITEC SUTURE PASSER |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | VESITEC MEDICAL, INC. 26072 MERIT CIRCLE SUITE 125 Laguna Hills, CA 92653 |
| Contact | Linda D'abate |
| Correspondent | Linda D'abate VESITEC MEDICAL, INC. 26072 MERIT CIRCLE SUITE 125 Laguna Hills, CA 92653 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-05-12 |