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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K943304
Device Name 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact BARRY E SANDS
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact BARRY E SANDS
Regulation Number876.1075
Classification Product Code
FCG  
Subsequent Product Code
FAL  
Date Received07/08/1994
Decision Date 12/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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