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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 K910432
Device Name HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
Applicant
Lifecore Biomedical, Inc.
1050 Connecticut Ave. NW
Wash. Sq. Suite 1100
Washington,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
Lifecore Biomedical, Inc.
1050 Connecticut Ave. NW
Wash. Sq. Suite 1100
Washington,  DC  20036
Correspondent Contact BRUCE F MACKLER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/31/1991
Decision Date 05/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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