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FDA 510(k), K221070, DP4 Microneedling device
FDA 510(k), K221070, DP4 Microneedling device
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510(K) Number: K221070
Device Name: DP4 Microneedling device
Manufacturer: Shaun Kerrigan
Device Classification Name: Powered Microneedle Device
Regulation Number: QAI
Classification Product Code: KXA
Date Received: 04/12/2022
Decision Date: 12/20/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: DP4 Microneedling device
Manufacturer: Shaun Kerrigan
Device Classification Name: Powered Microneedle Device
Regulation Number: QAI
Classification Product Code: KXA
Date Received: 04/12/2022
Decision Date: 12/20/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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