FDA 510(k) Application Details - K992708

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K992708
Device Name Device, Iontophoresis, Other Uses
Applicant BIRCH POINT MEDICAL, INC.
2660 PATTON RD.
ROSEVILLE, MN 55113 US
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Contact WALTER L SEMBROWICH
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 08/11/1999
Decision Date 02/01/2000
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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