The following data is part of a premarket notification filed by Carefree Trading, Inc. with the FDA for Lifemask Face Shield.
| Device ID | K953824 |
| 510k Number | K953824 |
| Device Name: | LIFEMASK FACE SHIELD |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1995-09-19 |