The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Silicone Retinal Implants/explants.
Device ID | K945172 |
510k Number | K945172 |
Device Name: | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS |
Classification | Implant, Orbital, Extra-ocular |
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 | HQX |
CFR Regulation Number | 886.3340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-21 |
Decision Date | 1995-01-17 |