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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gown, surgical
510(k) Number K121152
Device Name SURGICAL GOWN, SMS
Original Applicant
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
7305 hancock village dr
suite 109
chesterfield,  VA  23832
Original Contact darren reeves
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/16/2012
Decision Date 12/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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