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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sigmoidoscope And Accessories, Flexible/Rigid
510(k) Number K812965
Device Name MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
Applicant
AMERICAN OPTICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN OPTICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FAM  
Date Received10/22/1981
Decision Date 11/02/1981
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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