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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 K030682
Device Name CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
Applicant
Bioform, Inc.
4133 Courtney Rd., #10
Franksville,  WI  53126
Applicant Contact WILLIAM G HUBBARD
Correspondent
Bioform, Inc.
4133 Courtney Rd., #10
Franksville,  WI  53126
Correspondent Contact WILLIAM G HUBBARD
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/05/2003
Decision Date 06/27/2003
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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