The following data is part of a premarket notification filed by Precept, Inc. with the FDA for Mask, Face, Surgical.
| Device ID | K770021 |
| 510k Number | K770021 |
| Device Name: | MASK, FACE, SURGICAL |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PRECEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-01-06 |
| Decision Date | 1977-01-17 |