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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
Device Name SAFEAIR SMOKE PENCIL,
Applicant
Lna Medical Aps
611 W. 5th St.
Austin,  TX  78701
Applicant Contact RICK GILLIS, PH.D
Correspondent
Lna Medical Aps
611 W. 5th St.
Austin,  TX  78701
Correspondent Contact RICK GILLIS, PH.D
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/14/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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