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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 K122200
Device Name A3F FRATIONAL
Applicant
Pollogen, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
Pollogen, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/25/2012
Decision Date 04/18/2013
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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