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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 K121977
Model PS10-2130 (VERSION 3-PLUS
Device Name PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
Applicant
PLASMA SURGICAL LIMITED
127 milton park
abingdon, oxfordshire, 
Contact peter gibson
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/05/2012
Decision Date 11/20/2012
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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