The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Precise-point.
| Device ID | K942234 |
| 510k Number | K942234 |
| Device Name: | VISITEC PRECISE-POINT |
| Classification | Suture, Nonabsorbable, Silk |
| 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 | GAP |
| Subsequent Product Code | GAT |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1994-07-12 |