The following data is part of a premarket notification filed by Bay State Anesthesia, Inc. with the FDA for Insulin Syringe Guide.
Device ID | K903426 |
510k Number | K903426 |
Device Name: | INSULIN SYRINGE GUIDE |
Classification | Syringe, Piston |
Applicant | BAY STATE ANESTHESIA, INC. 30 WILLOW ST. North Andover, MA 01845 |
Contact | William J Galpin |
Correspondent | William J Galpin BAY STATE ANESTHESIA, INC. 30 WILLOW ST. North Andover, MA 01845 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-31 |
Decision Date | 1990-09-26 |