FDA 510(k) Application Details - K052479

Device Classification Name Bath, Hydro-Massage

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510(K) Number K052479
Device Name Bath, Hydro-Massage
Applicant ENNEKING MEDICAL INC.
1801 GUINOTTE AVE.
KANSAS CITY, MO 64120 US
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Contact STEPHEN WHITTENBURG
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Regulation Number 890.5100

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Classification Product Code ILJ
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Date Received 09/09/2005
Decision Date 01/26/2006
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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