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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 K053643
Device Name STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
Applicant
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318 -3015
Applicant Contact BRIAN SMEKAL
Correspondent
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318 -3015
Correspondent Contact BRIAN SMEKAL
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/30/2005
Decision Date 01/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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