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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 K022368
Device Name DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
Applicant
CANOPUS MEDICAL SUPPLY CO., LTD.
10TH FL.,NO. 201
FU HSING NORTH ROAD
TAIPEI,  TW 105
Applicant Contact RUBY LIN
Correspondent
CANOPUS MEDICAL SUPPLY CO., LTD.
10TH FL.,NO. 201
FU HSING NORTH ROAD
TAIPEI,  TW 105
Correspondent Contact RUBY LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/22/2002
Decision Date 09/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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