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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 K943186
Device Name CAPSET CALCIUM SULFATE 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 Number872.3930
Classification Product Code
LYC  
Date Received07/05/1994
Decision Date 04/10/1995
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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