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FDA 510(k) Application Details - K013328
Device Classification Name
Bath, Paraffin
More FDA Info for this Device
510(K) Number
K013328
Device Name
Bath, Paraffin
Applicant
REMINGTON PRODUCTS COMPANY, L.L.C.
1400 SIXTEENTH ST. N.W.
SUITE 400
WASHINGTON, DC 20036 US
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Contact
PAMELA J FURMAN
Other 510(k) Applications for this Contact
Regulation Number
890.5110
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Classification Product Code
IMC
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More FDA Info for this Product Code
Date Received
10/05/2001
Decision Date
12/03/2001
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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