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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K070406
Device Name ENDODRAPE
Applicant
Vortek Surgical, LLC
1426 W. 29th St. Suite 300
Indianapolis,  IN  46208
Applicant Contact THOMAS SZYMCZAK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/12/2007
Decision Date 07/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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