The following data is part of a premarket notification filed by Precept, Inc. with the FDA for Disp. Surgical Face Mask.
| Device ID | K771409 |
| 510k Number | K771409 |
| Device Name: | DISP. SURGICAL FACE MASK |
| 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 | 1977-08-01 |
| Decision Date | 1977-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814707022685 | K771409 | 000 |
| 20368001105464 | K771409 | 000 |
| 20814707023354 | K771409 | 000 |
| 20814707020100 | K771409 | 000 |
| 20814707020117 | K771409 | 000 |
| 20814707020124 | K771409 | 000 |
| 20814707020148 | K771409 | 000 |
| 20814707020216 | K771409 | 000 |
| 20814707020230 | K771409 | 000 |
| 20814707020261 | K771409 | 000 |
| 20814707020483 | K771409 | 000 |
| 20814707020490 | K771409 | 000 |
| 20814707020506 | K771409 | 000 |
| 20814707020650 | K771409 | 000 |
| 20814707020674 | K771409 | 000 |
| 20814707020728 | K771409 | 000 |
| 20814707022661 | K771409 | 000 |
| 80368001105480 | K771409 | 000 |