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510(k) K032723

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR by Getinge USA, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2003
Date Received
September 3, 2003
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.

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  • K031259 — MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER (May 12, 2003)

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