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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Holder
510(k) Number K960068
Device Name SH-1 SURGICAL HOLDER FOR TELESCOPE
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Applicant Contact BARRY E SANDS
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Correspondent Contact BARRY E SANDS
Regulation Number876.1500
Classification Product Code
OCV  
Date Received01/05/1996
Decision Date 05/05/1997
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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