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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Malar
510(k) Number K961511
Device Name HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
Applicant
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Applicant Contact LYNN CUPERUS
Correspondent
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Correspondent Contact LYNN CUPERUS
Regulation Number878.3550
Classification Product Code
LZK  
Date Received04/19/1996
Decision Date 06/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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