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510(k) K031259

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER by Getinge USA, Inc. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2003
Date Received
April 21, 2003
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

Other clearances by Getinge USA, Inc.

  • K050664 — SPOR-TEST PA BIOLOGICAL INDICATOR KIT (April 7, 2005)
  • K032723 — BIOSIGN STEAM-24 BIOLOGICAL INDICATOR (October 1, 2003)
  • K031647 — BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (July 29, 2003)

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