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FDA 510(k), K182003, Lympha Press Optimal Plus
FDA 510(k), K182003, Lympha Press Optimal Plus
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510(K) Number: K182003
Device Name: Lympha Press Optimal Plus
Manufacturer: Reuven Yunger
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: KXA
Date Received: 07/26/2018
Decision Date: 02/27/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Lympha Press Optimal Plus
Manufacturer: Reuven Yunger
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: KXA
Date Received: 07/26/2018
Decision Date: 02/27/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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