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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 K103504
Device Name GETINGE 400HC/500HC SERIES STEAM STERILIZER
Applicant
Getinge Sourcing, LLC
1777 E. Henrietta Rd.
Rochester,  NY  14623
Applicant Contact BARB SMITH
Correspondent
Getinge Sourcing, LLC
1777 E. Henrietta Rd.
Rochester,  NY  14623
Correspondent Contact BARB SMITH
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/26/2010
Decision Date 03/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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