The following data is part of a premarket notification filed by Gainor Medical with the FDA for Gainor Medical Syringe.
Device ID | K844306 |
510k Number | K844306 |
Device Name: | GAINOR MEDICAL SYRINGE |
Classification | Syringe, Piston |
Applicant | GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
Contact | Mark Gainor |
Correspondent | Mark Gainor GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-06 |
Decision Date | 1984-11-30 |