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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 K120454
Model SHK-VS-US, SHK-VS-RS-US
Device Name SAFEAIR SMOKE PENCIL,
Applicant
LNA MEDICAL APS
611 w 5th st
austin,  TX  78701
Contact rick gillis, ph.d
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/14/2012
Decision Date 12/07/2012
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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