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FDA 510(k), K182774, STOP U (Packed Black USA), STOP U (Packed White USA)
FDA 510(k), K182774, STOP U (Packed Black USA), STOP U (Packed White USA)
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$149.00 USD
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510(K) Number: K182774
Device Name: STOP U (Packed Black USA), STOP U (Packed White USA)
Manufacturer: Pollogen Ltd.
Device Classification Name: over-the-counter radiofrequency coagulation device for wrinkle reduction
Regulation Number: 878.4420
Classification Product Code: PAY
Date Received: 10/01/2018
Decision Date: 06/19/2019
Regulation Medical Specialty: General & Plastic Surgery
Device Name: STOP U (Packed Black USA), STOP U (Packed White USA)
Manufacturer: Pollogen Ltd.
Device Classification Name: over-the-counter radiofrequency coagulation device for wrinkle reduction
Regulation Number: 878.4420
Classification Product Code: PAY
Date Received: 10/01/2018
Decision Date: 06/19/2019
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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