FDA 510(k) Application Details - K010031

Device Classification Name Device, Iontophoresis, Specific Uses

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510(K) Number K010031
Device Name Device, Iontophoresis, Specific Uses
Applicant WESCOR, INC.
459 SOUTH MAIN
LOGAN, UT 84321 US
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Contact WAYNE K BARLOW
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Regulation Number 890.5525

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Classification Product Code KTB
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Date Received 01/03/2001
Decision Date 03/20/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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