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FDA 510(k), K193654, BlueStar Rx
FDA 510(k), K193654, BlueStar Rx
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$89.00 USD
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$89.00 USD
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510(K) Number: K193654
Device Name: BlueStar Rx
Manufacturer: WellDoc, Inc
Device Classification Name: accessories, pump, infusion
Regulation Number: 880.5725
Classification Product Code: MRZ
Date Received: 12/30/2019
Decision Date: 04/07/2020
Regulation Medical Specialty: General Hospital
Device Name: BlueStar Rx
Manufacturer: WellDoc, Inc
Device Classification Name: accessories, pump, infusion
Regulation Number: 880.5725
Classification Product Code: MRZ
Date Received: 12/30/2019
Decision Date: 04/07/2020
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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