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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 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Applicant Contact BARB SMITH
Correspondent
GETINGE SOURCING LLC
1777 EAST 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
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