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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 K983811
Device Name UNIPOLAR OPTICAL BIOPSY FORCEPS
Applicant
Olympus Winter & Ibe GmbH
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Winter & Ibe GmbH
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.4300
Classification Product Code
KGE  
Date Received10/28/1998
Decision Date 12/24/1998
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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