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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K941357
Device Name VINYL EXAMINATION GLOVE, POWDER FREE
Applicant
Canopus Medical Supply Co., Ltd.
9fl, # 50, Fu-Hsing N. Rd.
Taipei,  TW
Applicant Contact RUBY LIN
Correspondent
Canopus Medical Supply Co., Ltd.
9fl, # 50, Fu-Hsing N. Rd.
Taipei,  TW
Correspondent Contact RUBY LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/21/1994
Decision Date 04/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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