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FDA 510(k), K223893, Infrared Heat (Model: E0221)
FDA 510(k), K223893, Infrared Heat (Model: E0221)
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
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per
510(K) Number: K223893
Device Name: Infrared Heat (Model: E0221)
Manufacturer: Alain Dijkstra
Device Classification Name: Light Based Over The Counter Wrinkle Reduction
Regulation Number: OHS
Classification Product Code: KXA
Date Received: 12/28/2022
Decision Date: 05/16/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Infrared Heat (Model: E0221)
Manufacturer: Alain Dijkstra
Device Classification Name: Light Based Over The Counter Wrinkle Reduction
Regulation Number: OHS
Classification Product Code: KXA
Date Received: 12/28/2022
Decision Date: 05/16/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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