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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 K102461
Device Name FRACTORA
Applicant
Invasix , Ltd.
Apolo Bldg.
Pob 533
Yokneam Illit,  IL 20692
Applicant Contact AMIR WALDMAN
Correspondent
Invasix , Ltd.
Apolo Bldg.
Pob 533
Yokneam Illit,  IL 20692
Correspondent Contact AMIR WALDMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/27/2010
Decision Date 06/02/2011
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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