The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Aspirating Syringe.
Device ID | K923645 |
510k Number | K923645 |
Device Name: | VISITEC ASPIRATING SYRINGE |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-21 |
Decision Date | 1992-09-30 |