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FDA 510(k), K191491, EZ-Cover
FDA 510(k), K191491, EZ-Cover
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$149.00 USD
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510(K) Number: K191491
Device Name: EZ-Cover
Manufacturer: Katherine Hughey
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: 06/05/2019
Date Received: 06/05/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: EZ-Cover
Manufacturer: Katherine Hughey
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: 06/05/2019
Date Received: 06/05/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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