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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 K042730
Device Name CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
Applicant
LIFECORE BIOMEDICAL
3515 LYMAN BLVD.
CHASKA,  MN  55318
Applicant Contact JEREMY HUOTARI
Correspondent
LIFECORE BIOMEDICAL
3515 LYMAN BLVD.
CHASKA,  MN  55318
Correspondent Contact JEREMY HUOTARI
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/01/2004
Decision Date 02/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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