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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
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