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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
Applicant
Nsi
611 W. 5th St.
Austin,  TX  78701
Applicant Contact GORDON WEHNER
Correspondent
Nsi
611 W. 5th St.
Austin,  TX  78701
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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