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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 K122092
Device Name MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
Original Applicant
MEDRANGE CORPORATION
480 apollo st ste d
brea,  CA  92821
Original Contact kuofang huang
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/16/2012
Decision Date 10/23/2012
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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