The following data is part of a premarket notification filed by Martech Medical Products, Inc. with the FDA for Marksman Arterial Blood Gas Syringe.
Device ID | K910970 |
510k Number | K910970 |
Device Name: | MARKSMAN ARTERIAL BLOOD GAS SYRINGE |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | MARTECH MEDICAL PRODUCTS, INC. 7555 JURUPA AVE. SUITE E Riverside, CA 92504 |
Contact | Michael D Martell |
Correspondent | Michael D Martell MARTECH MEDICAL PRODUCTS, INC. 7555 JURUPA AVE. SUITE E Riverside, CA 92504 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-07 |
Decision Date | 1991-10-15 |