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FDA 510(k) Application Details - K052875
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K052875
Device Name
Electrode, Cutaneous
Applicant
SUMMIT MANUFACTURING, L.L.C.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
10/12/2005
Decision Date
12/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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