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510(k) K241710

3M Attest Super Rapid Readout Biological Indicator 1492V; 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: September 12, 2024
Date Received: June 14, 2024
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

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