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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 K120510
Device Name TRANSCEND
Original Applicant
SYNERON MEDICAL LTD.
industrial zone, tavor
building, p.o.b. 550
yokneam illit,  IL 20692
Original Contact sam wade
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/21/2012
Decision Date 07/19/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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