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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
Applicant
Orthovita, Inc.
77 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact John Urtz
Correspondent
Orthovita, Inc.
77 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent 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 Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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