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FDA 510(k) Application Details - K973865
Device Classification Name
Lamp,Uvc,(For Treating Skin And Wounds)
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510(K) Number
K973865
Device Name
Lamp,Uvc,(For Treating Skin And Wounds)
Applicant
MEDFAXX, INC.
P.O. BOX 17827
RALEIGH, NC 27619-7827 US
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Contact
BOB JOHNSON
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Regulation Number
000.0000
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Classification Product Code
MXG
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More FDA Info for this Product Code
Date Received
10/06/1997
Decision Date
02/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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