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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 K993242
Device Name CASTLE SURGICAL LIGHT, MODEL 3000
Applicant
Getinge/Castle, Inc.
7371 Spartan Blvd. E.
North Charleston,  SC  29418
Applicant Contact PETER L KOSTE
Correspondent
Getinge/Castle, Inc.
7371 Spartan Blvd. E.
North Charleston,  SC  29418
Correspondent Contact PETER L KOSTE
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/27/1999
Decision Date 11/08/1999
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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