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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 K080341
Device Name ENDODRAPE(TM)
Applicant
Vortek Surgical, LLC
1426 W. 29th St. Suite 300
Indianapolis,  IN  46208
Applicant Contact THOMAS SZYMCZAK
Correspondent
Vortek Surgical, LLC
1426 W. 29th St. Suite 300
Indianapolis,  IN  46208
Correspondent Contact THOMAS SZYMCZAK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/08/2008
Decision Date 07/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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