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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Fiber Optic
510(k) Number K882061
Device Name OLYMPUS GF-UM3/EU-M3
Applicant
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact HIROYUKI SASA
Correspondent
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact HIROYUKI SASA
Regulation Number876.1500
Classification Product Code
GDB  
Date Received05/16/1988
Decision Date 11/15/1988
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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