The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Marquest Micro Stik 9000 Series.
Device ID | K842008 |
510k Number | K842008 |
Device Name: | MARQUEST MICRO STIK 9000 SERIES |
Classification | Arterial Blood Sampling Kit |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle Suite A Englewood, CO 80112 |
Contact | John G Adams |
Correspondent | John G Adams 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 | 1984-05-17 |
Decision Date | 1984-05-25 |