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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
Other 510(k) Applications for this Contact
Regulation Number
890.5100
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Classification Product Code
ILJ
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More FDA Info for this Product Code
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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