The following data is part of a premarket notification filed by Precept, Inc. with the FDA for Mask, Surgical, Face, Disposable.
| Device ID | K770463 |
| 510k Number | K770463 |
| Device Name: | MASK, SURGICAL, FACE, DISPOSABLE |
| Classification | Mask, Surgical |
| Applicant | PRECEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-09 |
| Decision Date | 1977-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814707022678 | K770463 | 000 |
| 20814707020131 | K770463 | 000 |
| 20814707020094 | K770463 | 000 |
| 20814707020087 | K770463 | 000 |
| 20814707020070 | K770463 | 000 |
| 20814707020063 | K770463 | 000 |
| 20814707020056 | K770463 | 000 |
| 20814707020049 | K770463 | 000 |
| 20814707020032 | K770463 | 000 |
| 20814707020025 | K770463 | 000 |
| 00814707029994 | K770463 | 000 |
| 00814707023367 | K770463 | 000 |
| 20814707020629 | K770463 | 000 |
| 20368001105457 | K770463 | 000 |
| 80368001105442 | K770463 | 000 |
| 20814707020155 | K770463 | 000 |
| 20814707020162 | K770463 | 000 |
| 20814707020179 | K770463 | 000 |
| 20814707020711 | K770463 | 000 |
| 20814707020643 | K770463 | 000 |
| 20814707020476 | K770463 | 000 |
| 20814707020445 | K770463 | 000 |
| 20814707020438 | K770463 | 000 |
| 20814707020421 | K770463 | 000 |
| 20814707020414 | K770463 | 000 |
| 20814707020407 | K770463 | 000 |
| 20814707020391 | K770463 | 000 |
| 20814707020360 | K770463 | 000 |
| 20814707020339 | K770463 | 000 |
| 20814707020254 | K770463 | 000 |
| 20814707020209 | K770463 | 000 |
| 20814707020186 | K770463 | 000 |
| 80368001105435 | K770463 | 000 |