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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K100346
Device Name ENDOCLEAR SYSTEM
Applicant
Virtual Ports, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
Virtual Ports, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/12/2010
Decision Date 03/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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