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FDA 510(k) Application Details - K213813
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K213813
Device Name
Clip, Implantable
Applicant
NeuraMedica Inc
402 Beavercreek Road, Suite 110
Oregon City, OR 97045 US
Other 510(k) Applications for this Company
Contact
Rachel Dreilinger
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
FZP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/07/2021
Decision Date
07/22/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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