The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Circuit, Breathing.
Device ID | K811700 |
510k Number | K811700 |
Device Name: | CIRCUIT, BREATHING |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle Suite A Englewood, CO 80112 |
Contact | Robert J Mckinnon |
Correspondent | Robert J Mckinnon MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle, Suite A Englewood, CO 80112 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-16 |
Decision Date | 1981-07-10 |