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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 K122625
Device Name GETINGE 800HC- SERIES STEAM STERILIZER
Applicant
Getinge Sourcing, LLC
1777 E. Henrietta Rd.
Rochester,  NY  14623 -3133
Applicant Contact BARB SMITH
Correspondent
Getinge Sourcing, LLC
1777 E. Henrietta Rd.
Rochester,  NY  14623 -3133
Correspondent Contact BARB SMITH
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/28/2012
Decision Date 05/22/2013
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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