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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K093390
Device Name HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
Applicant
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact SHARON STAROWICZ
Correspondent
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact SHARON STAROWICZ
Regulation Number872.3930
Classification Product Code
LYC  
Subsequent Product Code
NPM  
Date Received10/29/2009
Decision Date 05/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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