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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K994314
Device Name CASTLE SERIES 100HC STEAM STERILIZERS
Applicant
GETINGE/CASTLE, INC.
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Applicant Contact MARK N SMITH
Correspondent
GETINGE/CASTLE, INC.
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Correspondent Contact MARK N SMITH
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/22/1999
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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