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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
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
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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