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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 K121919
Model 20-121
Device Name SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
Original Applicant
EXACT MEDICAL MANUFACTURING, INC
1083 delaware ave
buffalo,  NY  14209
Original Contact robert o dean
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/02/2012
Decision Date 02/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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