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 |