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FDA 510(k), K220641, Barrigel Injectable Gel
FDA 510(k), K220641, Barrigel Injectable Gel
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$149.00 USD
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$149.00 USD
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510(K) Number: K220641
Device Name: Barrigel Injectable Gel
Manufacturer: Palette Life Sciences
Device Classification Name: Hydrogel Spacer
Regulation Number: 892.5725
Classification Product Code: OVB
Date Received: 03/04/2022
Decision Date: 05/26/2022
Regulation Medical Specialty: Radiology
Device Name: Barrigel Injectable Gel
Manufacturer: Palette Life Sciences
Device Classification Name: Hydrogel Spacer
Regulation Number: 892.5725
Classification Product Code: OVB
Date Received: 03/04/2022
Decision Date: 05/26/2022
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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