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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 K122071
Model 422HC-E, 433HC-E, 522HC-E, 533HC-E
Device Name GETINGE 400HC-E / 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 Received07/16/2012
Decision Date 03/12/2013
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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