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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, iontophoresis, other uses
510(k) Number K191436
Device Name Saalio
Saalmann medical GmbH & Co. KG
Sudbahnstrabe 34
bad oeynhausen,  DE 32547
Applicant Contact rolf eilers
BEO MedConsulting Berlin GmbH
Helmholtzstr. 2
berlin,  DE 10587
Correspondent Contact michael vent
Regulation Number890.5525
Classification Product Code
Date Received05/30/2019
Decision Date 10/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No