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FDA 510(k), K162945, VERIFY ASSERT STEAM Process Challenge Device
FDA 510(k), K162945, VERIFY ASSERT STEAM Process Challenge Device
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510(K) Number: K162945
Device Name: VERIFY ASSERT STEAM Process Challenge Device
Manufacturer: STERIS Corporation
Device Classification Name: biological sterilization process indicator with recombinant-dna plasmid
Regulation Number: 880.2805
Classification Product Code: OWP
Date Received: 10/21/2016
Decision Date: 04/28/2017
Regulation Medical Specialty: General Hospital
Device Name: VERIFY ASSERT STEAM Process Challenge Device
Manufacturer: STERIS Corporation
Device Classification Name: biological sterilization process indicator with recombinant-dna plasmid
Regulation Number: 880.2805
Classification Product Code: OWP
Date Received: 10/21/2016
Decision Date: 04/28/2017
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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