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510(k) K210481

Instant 20s Indicator by True Indicating, LLC — Product Code MTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2021
Date Received
February 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code MTC

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