The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Disposable Non-rebreathing Anes. Circuit.
Device ID | K823714 |
510k Number | K823714 |
Device Name: | DISPOSABLE NON-REBREATHING ANES. CIRCUIT |
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 | 1982-12-10 |
Decision Date | 1983-01-07 |