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FDA 510(k) Application Details - K110994
Device Classification Name
Bath, Hydro-Massage
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510(K) Number
K110994
Device Name
Bath, Hydro-Massage
Applicant
ARJOHUNTLEIGH INC
2349 WEST LAKE STREET
SUITE 250
ADDISON, IL 60101 US
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Contact
BRENDA AMMONETTE
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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
04/08/2011
Decision Date
07/06/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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