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FDA 510(k) Application Details - K150924
Device Classification Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
More FDA Info for this Device
510(K) Number
K150924
Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant
ANCHOR INNOVATION MEDICAL (A.I.M.)
5410 EDSON LANE, SUITE 308
ROCKVILLE, MD 20852 US
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Contact
CARY STALNECKER
Other 510(k) Applications for this Contact
Regulation Number
882.5880
More FDA Info for this Regulation Number
Classification Product Code
GZB
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More FDA Info for this Product Code
Date Received
04/06/2015
Decision Date
07/27/2015
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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