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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K120373
Model 2030
Device Name INSORB ABSORBALBE STAPLE
Original Applicant
INCISIVE SURGICAL, INC.
14405 21st ave n.
suite 130
plymouth,  MN  55447
Original Contact david herridge
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/06/2012
Decision Date 03/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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