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510(k) K122071

GETINGE 400HC-E / SERIES STEAM STERILIZER by Getinge Sourcing, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2013
Date Received
July 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

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  • K120441 — GETINGE 700HC-E SERIES STEAM STERILIZER (May 31, 2012)
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  • K070657 — GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER (April 5, 2007)

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