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510(k) DEN230068

3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 by 3M Company — Product Code JOJ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 21, 2024
Date Received: September 29, 2023
Clearance Type: Direct
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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