The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Microsurgical Suture.
| Device ID | K922530 |
| 510k Number | K922530 |
| Device Name: | VISITEC MICROSURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | David A Clapp |
| Correspondent | David A Clapp VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1992-10-20 |