The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Surgical Face Mask.
| Device ID | K905749 |
| 510k Number | K905749 |
| Device Name: | SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Contact | Steven Robinson |
| Correspondent | Steven Robinson ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-03-04 |