The following data is part of a premarket notification filed by Princeton Medical Instruments, Inc. with the FDA for Ms 16 Syringe Driver.
Device ID | K802400 |
510k Number | K802400 |
Device Name: | MS 16 SYRINGE DRIVER |
Classification | Pump, Infusion |
Applicant | PRINCETON MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-02 |
Decision Date | 1980-12-16 |