The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Respir Gard Bacteria Filter.
| Device ID | K833269 |
| 510k Number | K833269 |
| Device Name: | RESPIR GARD BACTERIA FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1983-10-31 |