The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Irrigation Control System.
Device ID | K853243 |
510k Number | K853243 |
Device Name: | VISITEC IRRIGATION CONTROL SYSTEM |
Classification | Device, Irrigation, Ocular Surgery |
Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
Contact | Thomas B Givens |
Correspondent | Thomas B Givens VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
Product Code | KYG |
CFR Regulation Number | 886.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-01 |
Decision Date | 1985-09-11 |