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FDA 510(k) Application Details - K170242
Device Classification Name
Generator, Lesion, Radiofrequency
More FDA Info for this Device
510(K) Number
K170242
Device Name
Generator, Lesion, Radiofrequency
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO, MI 49001 US
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Contact
BECKY DITTY
Other 510(k) Applications for this Contact
Regulation Number
882.4400
More FDA Info for this Regulation Number
Classification Product Code
GXD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/26/2017
Decision Date
05/25/2017
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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