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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 K950567
Device Name BIO-APATITE 6140 HA PARTICLES
Applicant
BIO-INTERFACES, INC.
11095 FLINTKOTE AVE.
SAN DIEGO,  CA  92121
Applicant Contact JOHN F KAY
Correspondent
BIO-INTERFACES, INC.
11095 FLINTKOTE AVE.
SAN DIEGO,  CA  92121
Correspondent Contact JOHN F KAY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/08/1995
Decision Date 05/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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