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FDA 510(k) Application Details - K202901
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
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510(K) Number
K202901
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
Longeviti Neuro Solutions, LLC
303 International Circle Suite 190
Hunt Valley, MD 21030 US
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Contact
Heather Hourihan
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Regulation Number
882.5330
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Classification Product Code
GXN
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More FDA Info for this Product Code
Date Received
09/29/2020
Decision Date
10/30/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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