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510(k) K242860

Type 5 Integrating Indicator for Steam (CSPN-15) by True Indicating, LLC — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
September 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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