The following data is part of a premarket notification filed by Visitec Co. with the FDA for Ophthalmic Fluid Distribution Sets.
Device ID | K923972 |
510k Number | K923972 |
Device Name: | OPHTHALMIC FLUID DISTRIBUTION SETS |
Classification | Tubing, Fluid Delivery |
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 | FPK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-07 |
Decision Date | 1992-11-04 |