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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K072241
Device Name PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
Applicant
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318
Applicant Contact JUDITH MEDLOCK-HAYES
Correspondent
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318
Correspondent Contact JUDITH MEDLOCK-HAYES
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
ELL  
Date Received08/13/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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