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 |