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510(k) K120532

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM by Getinge Sourcing, LLC — Product Code PEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2013
Date Received
February 22, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer Automated Loading System
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.

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