FDA 510(k) Application Details - K993872

Device Classification Name Bath, Hydro-Massage

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510(K) Number K993872
Device Name Bath, Hydro-Massage
Applicant VANCARE, INC.
1515 1ST ST.
AURORA, NE 68818 US
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Contact JAMES A VANDERHEIDEN
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Regulation Number 890.5100

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Classification Product Code ILJ
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Date Received 11/15/1999
Decision Date 02/16/2000
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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