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FDA 510(k), K171003, 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
FDA 510(k), K171003, 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
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510(K) Number: K171003
Device Name: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
Manufacturer: Hilary B. Hovde
Device Classification Name: Indicator, Biological Sterilization Process
Regulation Number: FRC
Classification Product Code: KXA
Date Received: 04/04/2017
Decision Date: 07/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
Manufacturer: Hilary B. Hovde
Device Classification Name: Indicator, Biological Sterilization Process
Regulation Number: FRC
Classification Product Code: KXA
Date Received: 04/04/2017
Decision Date: 07/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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