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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K050689
Device Name SURGICAL FACE MASK
Applicant
CHINA SURGICAL DRESSINGS CENTER CO.,LTD
4 F. 232 JEN AI RD., SEC. 4
TAIPEI, TAIWAN,  TW
Applicant Contact MICHAEL F. L CHANG
Correspondent
CHINA SURGICAL DRESSINGS CENTER CO.,LTD
4 F. 232 JEN AI RD., SEC. 4
TAIPEI, TAIWAN,  TW
Correspondent Contact MICHAEL F. L CHANG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/17/2005
Decision Date 10/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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