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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 K122966
Device Name XP200
Applicant
BTL INDUSTRIES LTD
611 west 5th street
third floor
austin,  TX  78701
Contact richard vincins
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/25/2012
Decision Date 04/08/2013
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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