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510(k) K070657

GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER by Getinge Sourcing, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2007
Date Received
March 9, 2007
Clearance Type
Special
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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  • K122071 — GETINGE 400HC-E / SERIES STEAM STERILIZER (March 12, 2013)
  • K120441 — GETINGE 700HC-E SERIES STEAM STERILIZER (May 31, 2012)
  • K103504 — GETINGE 400HC/500HC SERIES STEAM STERILIZER (March 16, 2011)

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