FDA 510(k), K191653, Freestyle Flex
FDA 510(k), K191653, Freestyle Flex
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510(K) Number: K191653
Device Name: Freestyle Flex
Manufacturer: Medela AG
Device Classification Name: pump, breast, powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 06/20/2019
Decision Date: 10/17/2019
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Freestyle Flex
Manufacturer: Medela AG
Device Classification Name: pump, breast, powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 06/20/2019
Decision Date: 10/17/2019
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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