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FDA 510(k), K220506, SkinPen Precision System
FDA 510(k), K220506, SkinPen Precision System
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$149.00 USD
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$149.00 USD
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510(K) Number: K220506
Device Name: SkinPen Precision System
Manufacturer: Marie Fogartie
Device Classification Name: Powered Microneedle Device
Regulation Number: QAI
Classification Product Code: 02/22/2022
Date Received: 03/07/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SkinPen Precision System
Manufacturer: Marie Fogartie
Device Classification Name: Powered Microneedle Device
Regulation Number: QAI
Classification Product Code: 02/22/2022
Date Received: 03/07/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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