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 | K931924 |
510k Number | K931924 |
Device Name: | MARKSMAN ARTERIAL BLOOD GAS SYRINGE |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | MARTECH MEDICAL PRODUCTS, INC. 43223 BUSINESS PARK DR. Temecula, CA 92590 |
Contact | Steven F Mercereau |
Correspondent | Steven F Mercereau MARTECH MEDICAL PRODUCTS, INC. 43223 BUSINESS PARK DR. Temecula, CA 92590 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-16 |
Decision Date | 1993-08-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10709078013536 | K931924 | 000 |
10709078013512 | K931924 | 000 |
10709078013499 | K931924 | 000 |
10709078013475 | K931924 | 000 |
10709078013451 | K931924 | 000 |
10709078013352 | K931924 | 000 |
10709078013338 | K931924 | 000 |
10709078006484 | K931924 | 000 |