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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K940228
Device Name BOUFFANT CAP
Applicant
Derekduck Industries Corp.
18 Shaohsing S. St.
Taipei,Taiwan,  CN
Applicant Contact DEREK LIN
Correspondent
Derekduck Industries Corp.
18 Shaohsing S. St.
Taipei,Taiwan,  CN
Correspondent Contact DEREK LIN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received01/14/1994
Decision Date 09/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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