FDA 510(k) Application Details - K991991

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K991991
Device Name Device, Iontophoresis, Other Uses
Applicant EMPI
599 CARDIGAN RD.
ST. PAUL, MN 55126 US
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Contact KRISTY K MOLLNER
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 06/14/1999
Decision Date 09/10/1999
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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