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510(k) K113302

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS by North American Science Assoc., Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
November 8, 2011
Clearance Type
Abbreviated
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

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  • K962649 — SPORTROL RAPID STERILITY INDICATOR (September 26, 1997)

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