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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 K153230
Device Name ShefaBone SCPC Resorbable Bone Graft
Applicant
The Implantech Inc./Shefabone
9016 Cliff Cameron Dr., #201
Charlotte,  NC  28269
Applicant Contact AHMED EL-GHANNAM
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received11/06/2015
Decision Date 07/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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