The following data is part of a premarket notification filed by Carefree Trading, Inc. with the FDA for Cpr Life Mask Compact Barrier.
| Device ID | K954426 |
| 510k Number | K954426 |
| Device Name: | CPR LIFE MASK COMPACT BARRIER |
| Classification | Valve, Non-rebreathing |
| Applicant | CAREFREE TRADING, INC. 14602 NORTH CAVE CREEK RD., SUITE B Phoenix, AZ 85022 |
| Contact | Rick Stockett |
| Correspondent | Rick Stockett CAREFREE TRADING, INC. 14602 NORTH CAVE CREEK RD., SUITE B Phoenix, AZ 85022 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-22 |
| Decision Date | 1996-09-16 |