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FDA 510(k), K203768, Omnipod 5 ACE Pump (Pod)
FDA 510(k), K203768, Omnipod 5 ACE Pump (Pod)
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$49.00 USD
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510(K) Number: K203768
Device Name: Omnipod 5 ACE Pump (Pod)
Manufacturer: Alexander Hamad
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: KXA
Date Received: 12/23/2020
Decision Date: 01/27/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: Omnipod 5 ACE Pump (Pod)
Manufacturer: Alexander Hamad
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: KXA
Date Received: 12/23/2020
Decision Date: 01/27/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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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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