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FDA 510(k) Application Details - K011691
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K011691
Device Name
Electrode, Cutaneous
Applicant
KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C.
7651 S. 700 WEST
SUITE 105
SALT LAKE CITY, UT 84047 US
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Contact
DONALD F GRABARZ
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2001
Decision Date
12/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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