The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Respir Gard-ii Face Mask Corrugated Tubing.
| Device ID | K853056 |
| 510k Number | K853056 |
| Device Name: | RESPIR GARD-II FACE MASK CORRUGATED TUBING |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | John Adams |
| Correspondent | John Adams MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-08-07 |