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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K153306
Device Name Imbibe Needle
Applicant
Orthovita, Inc.
45 Great Valley Pkwy.
Malver,  PA  19355
Applicant Contact LYNN LUNDY
Correspondent
Orthovita, Inc.
77 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact LYNN LUNDY
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
LXH  
Date Received11/16/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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