The following data is part of a premarket notification filed by American Seal Co. with the FDA for Bouffant Cap.
| Device ID | K972187 |
| 510k Number | K972187 |
| Device Name: | BOUFFANT CAP |
| Classification | Drape, Surgical |
| Applicant | AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Contact | Joseph Tung |
| Correspondent | Joseph Tung AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-10 |
| Decision Date | 1997-09-09 |