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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drape, surgical
510(k) Number K122000
Models 935XXX-937XXX, 9381XX
Device Name HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
Original Applicant
CHANGZHOU HOLYMED PRODUCTS CO LTD
528 changwu road south
wujin district
changhou,  CH 213167
Original Contact alan yu
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/10/2012
Decision Date 12/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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