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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K130724
Device Name CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
Applicant
Straumann USA
6 0 Minuteman Rd.
Andover,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
Straumann USA
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/2013
Decision Date 06/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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