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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K870680
Device Name OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
Applicant
Medline Industries, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Applicant Contact JO BREHM
Correspondent
Medline Industries, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Correspondent Contact JO BREHM
Regulation Number876.1500
Classification Product Code
FET  
Date Received02/19/1987
Decision Date 04/17/1987
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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