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FDA 510(k) Application Details - K001860
Device Classification Name
Bath, Paraffin
More FDA Info for this Device
510(K) Number
K001860
Device Name
Bath, Paraffin
Applicant
HOMEDICS, INC.
3000 PONTIAC TRAIL
COMMERCE TOWNSHIP, MI 48390 US
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Contact
MICHEAL NELSON
Other 510(k) Applications for this Contact
Regulation Number
890.5110
More FDA Info for this Regulation Number
Classification Product Code
IMC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/19/2000
Decision Date
08/10/2000
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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