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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K133413
Device Name IDSS SLC
Applicant
Black Diamond Video
503 Canal Blvd.
Richmond,  CA  94804
Applicant Contact RAGUNATH MUNIANDY
Correspondent
Black Diamond Video
503 Canal Blvd.
Richmond,  CA  94804
Correspondent Contact RAGUNATH MUNIANDY
Regulation Number878.4580
Classification Product Code
FTA  
Date Received11/07/2013
Decision Date 01/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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