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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Nephroscope
510(k) Number K853486
Device Name OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact SCOTT J SOLANO
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact SCOTT J SOLANO
Regulation Number876.1500
Classification Product Code
FGA  
Date Received08/20/1985
Decision Date 09/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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