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510(k) K211705

3M Attest Rapid Readout Biological Indicator, 1295 by 3M Company — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2022
Date Received
June 3, 2021
Clearance Type
Special
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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