The following data is part of a premarket notification filed by Allison Medical, Inc. with the FDA for Allison Medical Syringe.
Device ID | K932001 |
510k Number | K932001 |
Device Name: | ALLISON MEDICAL SYRINGE |
Classification | Syringe, Piston |
Applicant | ALLISON MEDICAL, INC. 4301 SOUTH FEDERAL BLVD., SUITE 116 Englewood, CO 80110 |
Contact | Justin Ferrin |
Correspondent | Justin Ferrin ALLISON MEDICAL, INC. 4301 SOUTH FEDERAL BLVD., SUITE 116 Englewood, CO 80110 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-09 |
Decision Date | 1994-01-21 |