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FDA 510(k) Application Details - K170835
Device Classification Name
Device, Iontophoresis, Other Uses
More FDA Info for this Device
510(K) Number
K170835
Device Name
Device, Iontophoresis, Other Uses
Applicant
Hightech Development
Janovskeho 979/11
Prague 170 00 CZ
Other 510(k) Applications for this Company
Contact
Martin Boros
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
03/20/2017
Decision Date
06/15/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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