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Device Classification
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MTC — Indicator, Chemical, Enzymatic, Sterilization Process
Class II
FDA Device Classification
Classification Details
Product Code
MTC
Device Class
Class II
Regulation Number
880.2800
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K210481
true indicating
Instant 20s Indicator
December 14, 2021
K962649
north american science assoc
SPORTROL RAPID STERILITY INDICATOR
September 26, 1997