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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic manual surgical instrument
510(k) Number K140414
Device Name IMBIBE NEEDLE
Original Applicant
ORTHOVITA, INC.
77 great valley parkway
malvern,  PA  19355
Original Contact john urtz
Regulation Number888.4540
Classification Product Code
LXH  
Subsequent Product Code
KNW  
Date Received02/18/2014
Decision Date 04/01/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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