Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K170410
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
More FDA Info for this Device
510(K) Number
K170410
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
Longeviti Neuro Solutions, LLC
303 International Circle Suite T128
Hunt Valley, MD 21030 US
Other 510(k) Applications for this Company
Contact
Kevin Lee
Other 510(k) Applications for this Contact
Regulation Number
882.5330
More FDA Info for this Regulation Number
Classification Product Code
GXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2017
Decision Date
03/23/2018
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact