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510(k) K241836

Kem Medical Lead-free Chemical Indicators for Steam Sterilization by Kem Medical Products Corporation — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2024
Date Received
June 25, 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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