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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 K053382
Device Name LAPARO-THORACO VIDEOSCOPE XLTF-VAW
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact TRACY GULSEN
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact TRACY GULSEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/05/2005
Decision Date 05/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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