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FDA 510(k), K153727, INTRAcel Premium Fractional RF Micro Needle (FRM) System
FDA 510(k), K153727, INTRAcel Premium Fractional RF Micro Needle (FRM) System
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$149.00 USD
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510(K) Number: K153727
Device Name: INTRAcel Premium Fractional RF Micro Needle (FRM) System
Manufacturer: JEISYS MEDICAL, INC.
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 12/28/2015
Decision Date: 07/21/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: INTRAcel Premium Fractional RF Micro Needle (FRM) System
Manufacturer: JEISYS MEDICAL, INC.
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 12/28/2015
Decision Date: 07/21/2016
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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