FDA 510(k) Application Details - K031053

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K031053
Device Name Device, Iontophoresis, Other Uses
Applicant SELECTIVE MED COMPONENTS, INC.
201 WEST HIGH ST.
MOUNT VERNON, OH 43050 US
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Contact RICHARD J FISHER
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 04/02/2003
Decision Date 05/20/2003
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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