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FDA 510(k) Application Details - K203055
Device Classification Name
Plate, Cranioplasty, Preformed, Alterable
More FDA Info for this Device
510(K) Number
K203055
Device Name
Plate, Cranioplasty, Preformed, Alterable
Applicant
Stryker
750 Trade Centre Way - Suite 200
Portage, MI 49002 US
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Contact
Zainab Amini
Other 510(k) Applications for this Contact
Regulation Number
882.5320
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Classification Product Code
GWO
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More FDA Info for this Product Code
Date Received
10/08/2020
Decision Date
02/09/2021
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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