The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Respirgard.
| Device ID | K802763 |
| 510k Number | K802763 |
| Device Name: | RESPIRGARD |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 109 Inverness Drive East C1 Englewood, CO 80112 |
| Contact | Robert J Mckinnon |
| Correspondent | Robert J Mckinnon MARQUEST MEDICAL PRODUCTS, INC. 109 Inverness Drive East C1 Englewood, CO 80112 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-04 |
| Decision Date | 1980-11-26 |