FDA 510(k) Application Details - K170242

Device Classification Name Generator, Lesion, Radiofrequency

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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
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Regulation Number 882.4400

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Classification Product Code GXD
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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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