The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Omnistik, Mq 501gs.
| Device ID | K800860 |
| 510k Number | K800860 |
| Device Name: | OMNISTIK, MQ 501GS |
| Classification | Arterial Blood Sampling Kit |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 109 Inverness Drive East C1 Englewood, CO 80112 |
| Contact | Donald L Bailey |
| Correspondent | Donald L Bailey MARQUEST MEDICAL PRODUCTS, INC. 109 Inverness Drive East C1 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 | 1980-04-16 |
| Decision Date | 1980-04-29 |