The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Bouffant Cap.
| Device ID | K953878 |
| 510k Number | K953878 |
| Device Name: | BOUFFANT CAP |
| Classification | Cap, Surgical |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Contact | Gregory B Scott |
| Correspondent | Gregory B Scott AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Product Code | FYF |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-16 |
| Decision Date | 1996-01-05 |