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FDA 510(k), K200947, InMode System with the Morhpeus8 Applicators
FDA 510(k), K200947, InMode System with the Morhpeus8 Applicators
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$49.00 USD
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$49.00 USD
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510(K) Number: K200947
Device Name: InMode System with the Morhpeus8 Applicators
Manufacturer: Amit Goren
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 04/08/2020
Decision Date: 07/02/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: InMode System with the Morhpeus8 Applicators
Manufacturer: Amit Goren
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 04/08/2020
Decision Date: 07/02/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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