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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 K171262
Device Name TempSure
Applicant
Cynosure, Inc
5 Carlisle Road
westford,  MA  01886
Applicant Contact amy tannenbaum
Correspondent
Cynosure, Inc
5 Carlisle Road
westford,  MA  01886
Correspondent Contact amy tannenbaum
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received05/01/2017
Decision Date 09/22/2017
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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