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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 E. Henrietta Rd.
Rochester,  NY  14623 -3133
Applicant Contact MARK N SMITH
Correspondent
Getinge/Castle, Inc.
1777 E. 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
Predetermined Change
Control Plan Authorized		 No
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