FDA 510(k) Application Details - K964926

Device Classification Name Bath, Hydro-Massage

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510(K) Number K964926
Device Name Bath, Hydro-Massage
Applicant JOERNS HEALTHCARE, INC.
5001 JOERNS DR.
STEVENS POINT, WI 54481-5040 US
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Contact DEAN SOMMERFELD
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Regulation Number 890.5100

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Classification Product Code ILJ
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Date Received 12/09/1996
Decision Date 11/03/1997
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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