FDA 510(k), K181863, Elvie Pump
FDA 510(k), K181863, Elvie Pump
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510(K) Number: K181863
Device Name: Elvie Pump
Manufacturer: Chiaro Technology Limited
Device Classification Name: pump, breast, powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 07/12/2018
Decision Date: 10/10/2018
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Elvie Pump
Manufacturer: Chiaro Technology Limited
Device Classification Name: pump, breast, powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 07/12/2018
Decision Date: 10/10/2018
Regulation Medical Specialty: Obstetrics/Gynecology
- 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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