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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, jaw tracking, for monitoring jaw positions
510(k) Number K843951
Device Name SIROGNATHOGRAPH
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact BARBARA KLIER
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact BARBARA KLIER
Regulation Number872.2060
Classification Product Code
NFS  
Date Received10/09/1984
Decision Date 11/14/1984
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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