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FDA 510(k) Application Details - K191436
Device Classification Name
Device, Iontophoresis, Other Uses
More FDA Info for this Device
510(K) Number
K191436
Device Name
Device, Iontophoresis, Other Uses
Applicant
Saalmann medical GmbH & Co. KG
Sudbahnstrabe 34
Bad Oeynhausen 32547 DE
Other 510(k) Applications for this Company
Contact
Rolf Eilers
Other 510(k) Applications for this Contact
Regulation Number
890.5525
More FDA Info for this Regulation Number
Classification Product Code
EGJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/30/2019
Decision Date
10/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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