The following data is part of a premarket notification filed by American Seal Co. with the FDA for Amseal Surgical Face Mask.
| Device ID | K964358 |
| 510k Number | K964358 |
| Device Name: | AMSEAL SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Contact | Lisa Chen |
| Correspondent | Lisa Chen AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-02-14 |