The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Temp Marq(tm) Convective Warming System.
Device ID | K904690 |
510k Number | K904690 |
Device Name: | TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM |
Classification | System, Thermal Regulating |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Contact | Warren L Bisbee |
Correspondent | Warren L Bisbee MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-16 |
Decision Date | 1991-02-01 |