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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Central Control Unit
510(k) Number K153205
Device Name IDSS ForceTriad Control Module
Applicant
Black Diamond Video, Inc.
503 Canal Blvd.
Richmond,  CA  94804
Applicant Contact Ragunath Muniandy
Correspondent
Black Diamond Video, Inc.
503 Canal Blvd.
Richmond,  CA  94804
Correspondent Contact Ragunath Muniandy
Regulation Number876.1500
Classification Product Code
ODA  
Date Received11/04/2015
Decision Date 08/01/2016
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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