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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K894592
Device Name LAMANO DIRECTORS
Applicant
Marlo Surgical Technology
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact SCOTT MARLOW
Correspondent
Marlo Surgical Technology
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact SCOTT MARLOW
Regulation Number876.1500
Classification Product Code
GCM  
Date Received07/24/1989
Decision Date 09/08/1989
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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