The following data is part of a premarket notification filed by Medcare Disp Products, Inc. with the FDA for Syringe, Piston, Arterial Blood Sampl.
Device ID | K840924 |
510k Number | K840924 |
Device Name: | SYRINGE, PISTON, ARTERIAL BLOOD SAMPL |
Classification | Syringe, Piston |
Applicant | MEDCARE DISP PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-02 |
Decision Date | 1984-03-23 |