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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilizer automated loading system
510(k) Number K120532
Device Name GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
Original Applicant
GETINGE SOURCING LLC
1777 east henrietta rd.
rochester,  NY  14623 -3133
Original Contact barb smith
Regulation Number880.6880
Classification Product Code
PEC  
Date Received02/22/2012
Decision Date 05/02/2013
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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