The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visi-drape Ophthalmic Drapes.
Device ID | K902857 |
510k Number | K902857 |
Device Name: | VISI-DRAPE OPHTHALMIC DRAPES |
Classification | Keratome, Battery-powered |
Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
Contact | Liaquat Allarakhia |
Correspondent | Liaquat Allarakhia VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
Product Code | HMY |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-29 |
Decision Date | 1990-07-31 |