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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 K120581
Device Name SC TIP CLEANER
Original Applicant
NSI
611 west 5th st
austin,  TX  78701
Original Contact gordon wehner
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/27/2012
Decision Date 06/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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