The following data is part of a premarket notification filed by Derekduck Industries Corp. with the FDA for Bouffant Cap.
| Device ID | K940228 |
| 510k Number | K940228 |
| Device Name: | BOUFFANT CAP |
| Classification | Accessory, Surgical Apparel |
| Applicant | DEREKDUCK INDUSTRIES CORP. NO.18, SHAOHSING SOUTH ST. Taipei, Taiwan, R.o.c., CN |
| Contact | Derek Lin |
| Correspondent | Derek Lin DEREKDUCK INDUSTRIES CORP. NO.18, SHAOHSING SOUTH ST. Taipei, Taiwan, R.o.c., CN |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-14 |
| Decision Date | 1994-09-26 |