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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 K964131
Device Name ENDOSCOPE
Applicant
Akos Biomedical, Inc.
6450 Lusk Blvd., Suite 109
San Diego,  CA  92121
Applicant Contact LACYNE Y AVERY
Correspondent
Akos Biomedical, Inc.
6450 Lusk Blvd., Suite 109
San Diego,  CA  92121
Correspondent Contact LACYNE Y AVERY
Regulation Number876.1500
Classification Product Code
FAM  
Subsequent Product Code
FDF  
Date Received10/15/1996
Decision Date 06/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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