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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K141429
Device Name SORRENTO BONE GRAFT SUBSTITUTE
Applicant
Haider Biologics, LLC
9930 Mesa Rim Dr.
San Diego,  CA  92121
Applicant Contact GUSTAVO R PRADO
Correspondent
Haider Biologics, LLC
9930 Mesa Rim Dr.
San Diego,  CA  92121
Correspondent Contact GUSTAVO R PRADO
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/30/2014
Decision Date 02/23/2015
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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