The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Collar Button Catheter {griffiths}.
| Device ID | K953394 |
| 510k Number | K953394 |
| Device Name: | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} |
| Classification | Plug, Punctum |
| 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 | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1995-10-12 |