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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K051614
Device Name PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
Applicant
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318 -3015
Applicant Contact RACHEL KENNEDY
Correspondent
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318 -3015
Correspondent Contact RACHEL KENNEDY
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/17/2005
Decision Date 09/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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