The following data is part of a premarket notification filed by Safetec Of America, Inc. with the FDA for Cpr Mask & Related Family Kits.
| Device ID | K953461 |
| 510k Number | K953461 |
| Device Name: | CPR MASK & RELATED FAMILY KITS |
| Classification | Valve, Non-rebreathing |
| Applicant | SAFETEC OF AMERICA, INC. 1055 EAST DELAVAN AVE. Buffalo, NY 14215 |
| Contact | Robert O Dean |
| Correspondent | Robert O Dean SAFETEC OF AMERICA, INC. 1055 EAST DELAVAN AVE. Buffalo, NY 14215 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-24 |
| Decision Date | 1996-01-04 |