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FDA 510(k) Application Details - K211514
Device Classification Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
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510(K) Number
K211514
Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
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
878.3500
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Classification Product Code
KKY
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Date Received
05/17/2021
Decision Date
07/15/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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