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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
Original Applicant
PLASMA SURGICAL LIMITED
127 milton park
abingdon, oxfordshire,  UK ox14 4sa
Original 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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