The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Aspirator.
Device ID | K830312 |
510k Number | K830312 |
Device Name: | ASPIRATOR |
Classification | Arterial Blood Sampling Kit |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle Suite A Englewood, CO 80112 |
Contact | Mary Steggall |
Correspondent | Mary Steggall MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle Suite A 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 | 1983-01-26 |
Decision Date | 1983-05-25 |