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 |