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510(k) K050664

SPOR-TEST PA BIOLOGICAL INDICATOR KIT by Getinge USA, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2005
Date Received
March 15, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Getinge USA, Inc.

  • K032723 — BIOSIGN STEAM-24 BIOLOGICAL INDICATOR (October 1, 2003)
  • K031647 — BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (July 29, 2003)
  • K031259 — MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER (May 12, 2003)

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