The following data is part of a premarket notification filed by Airway Products, Inc. with the FDA for Non-rebreathing Airway And Mask(s) Kits.
| Device ID | K891124 |
| 510k Number | K891124 |
| Device Name: | NON-REBREATHING AIRWAY AND MASK(S) KITS |
| Classification | Valve, Non-rebreathing |
| Applicant | AIRWAY PRODUCTS, INC. 710 MAIN ST. - SUITE L Blue Springs, MO 64015 -2934 |
| Contact | Keith W Shepard |
| Correspondent | Keith W Shepard AIRWAY PRODUCTS, INC. 710 MAIN ST. - SUITE L Blue Springs, MO 64015 -2934 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-10-13 |