The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Micro-sponge Spears.
Device ID | K896705 |
510k Number | K896705 |
Device Name: | VISITEC MICRO-SPONGE SPEARS |
Classification | Sponge, Ophthalmic |
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 | HOZ |
CFR Regulation Number | 886.4790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-28 |
Decision Date | 1990-01-11 |