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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 K012573
Device Name CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
Applicant
Getinge/Castle, Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Applicant Contact FREDERICK R CATT
Correspondent
Getinge/Castle, Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Correspondent Contact FREDERICK R CATT
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/09/2001
Decision Date 09/05/2001
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
Predetermined Change
Control Plan Authorized		 No
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