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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K122086
Model 132-136D,132-132D,132-133D
Device Name THERMAL LIGATING SHEARS
Original Applicant
MICROLINE SURGICAL, INC
800 cumming center
suite 166t
beverly,  MA  01915
Original Contact william mccallum
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/16/2012
Decision Date 08/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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