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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
Model 833HC-E
Device Name GETINGE 800HC- SERIES STEAM STERILIZER
Original Applicant
GETINGE SOURCING LLC
1777 east henrietta rd.
rochester,  NY  14623 3133
Original Contact barb smith
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/28/2012
Decision Date 05/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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