FDA 510(k) Application Details - K170773

Device Classification Name Plate, Bone

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510(K) Number K170773
Device Name Plate, Bone
Applicant Stryker
750 Trade Centre Way - Suite 200
Portage, MI 49002 US
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Contact Gregory Gohl
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 03/14/2017
Decision Date 11/08/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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