The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Gas-lyte 1cc And 3cc Arterial Blood Samplers.
| Device ID | K902632 |
| 510k Number | K902632 |
| Device Name: | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS |
| Classification | Arterial Blood Sampling Kit |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | L Johnson |
| Correspondent | L Johnson MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-14 |
| Decision Date | 1990-09-04 |