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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K150394
Device Name Tyber Medical Wedge System
Applicant
TYBER MEDICAL LLC
89 HEADQUARTERS PLAZA NORTH
#1464
MORRISTOWN,  NJ  07960
Applicant Contact JEFF TYBER
Correspondent
TYBER MEDICAL LLC
89 HEADQUARTERS PLAZA NORTH
#1464
MORRISTOWN,  NJ  07960
Correspondent Contact JEFF TYBER
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Codes
HRS   HWC  
Date Received02/18/2015
Decision Date 07/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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