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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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