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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K062517
Device Name ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.4300
Classification Product Code
KGE  
Date Received08/28/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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