The following data is part of a premarket notification filed by Advanced Warming Systems, Inc. with the FDA for Disposable Adhesive Face Mask.
| Device ID | K950771 |
| 510k Number | K950771 |
| Device Name: | DISPOSABLE ADHESIVE FACE MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | ADVANCED WARMING SYSTEMS, INC. 3414 22ND ST. Lubbock, TX 79410 |
| Contact | Randy Hickle |
| Correspondent | Randy Hickle ADVANCED WARMING SYSTEMS, INC. 3414 22ND ST. Lubbock, TX 79410 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-21 |
| Decision Date | 1995-03-10 |