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FDA 510(k) Application Details - K171863
Device Classification Name
Component, Traction, Invasive
More FDA Info for this Device
510(K) Number
K171863
Device Name
Component, Traction, Invasive
Applicant
Anjon Holdings, LLC
4801 Dawin Rd
Jacksonville, FL 32207 US
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Contact
Tommy Mitchell
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
JEC
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More FDA Info for this Product Code
Date Received
06/22/2017
Decision Date
03/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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