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510(k) K233814

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) by 3M Company — Product Code FRC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 15, 2024
Date Received: November 30, 2023
Clearance Type: Traditional
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

Other clearances by 3M Company

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