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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 K960164
Device Name BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
Applicant
Bio-Interfaces, Inc.
11095 Flintkote Ave.
San Diego,  CA  92121
Applicant Contact JOHN F KAY, PH.D.
Correspondent
Bio-Interfaces, Inc.
11095 Flintkote Ave.
San Diego,  CA  92121
Correspondent Contact JOHN F KAY, PH.D.
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/16/1996
Decision Date 04/10/1996
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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