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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
Predetermined Change
Control Plan Authorized		 No
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