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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, ceiling mounted
510(k) Number K974084
Device Name GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
Applicant
GETINGE/CASTLE, INC.
7371 SPARTAN BLVD E.
NORTH CHARLESTON,  SC  29418
Applicant Contact TREVOR WILLIAMSON
Correspondent
GETINGE/CASTLE, INC.
7371 SPARTAN BLVD E.
NORTH CHARLESTON,  SC  29418
Correspondent Contact TREVOR WILLIAMSON
Regulation Number878.4580
Classification Product Code
FSY  
Date Received10/29/1997
Decision Date 03/03/1998
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
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