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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 K001169
Device Name OPTIVU HDVD SYSTEM
Applicant
Optimize, Inc.
420 Blossom Hill Rd.
Los Gatos,  CA  95032
Applicant Contact KEN GONG
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DONALD JAMES SHERATT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/11/2000
Decision Date 05/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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