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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 K961728
Device Name MIRUSCONE ABUTMENT SYSTEM
Applicant
NOBELPHARMA USA, INC.
777 OAKMONT LN.
SUITE 100
WESTMONT,  IL  60559
Applicant Contact MARY EDWARDS
Correspondent
NOBELPHARMA USA, INC.
777 OAKMONT LN.
SUITE 100
WESTMONT,  IL  60559
Correspondent Contact MARY EDWARDS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/03/1996
Decision Date 07/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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