The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Aspirator.
Device ID | K801620 |
510k Number | K801620 |
Device Name: | ASPIRATOR |
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 | 1980-07-15 |
Decision Date | 1980-07-21 |