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FDA 510(k) Application Details - K150394
Device Classification Name
More FDA Info for this Device
510(K) Number
K150394
Device Name
Tyber Medical Wedge System
Applicant
TYBER MEDICAL LLC
89 HEADQUARTERS PLAZA NORTH
#1464
MORRISTOWN, NJ 07960 US
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Contact
JEFF TYBER
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Regulation Number
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Classification Product Code
PLF
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Date Received
02/18/2015
Decision Date
07/28/2015
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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