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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K884857
Device Name COLONOSCOPE GUIDING TUBE DEVICE
Applicant
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Applicant Contact MARK KOZAK
Correspondent
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Correspondent Contact MARK KOZAK
Regulation Number876.1500
Classification Product Code
FDF  
Date Received11/21/1988
Decision Date 03/17/1989
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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