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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 K003226
Device Name THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
Applicant
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318
Applicant Contact CAROLYN ANDERSON
Correspondent
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318
Correspondent Contact CAROLYN ANDERSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/16/2000
Decision Date 01/12/2001
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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