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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 K952218
Device Name JT-3 ELECTROGNATHOGRAPH
Applicant
BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Applicant Contact JOHN C RADKE
Correspondent
BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Correspondent Contact JOHN C RADKE
Regulation Number872.2060
Classification Product Code
NFS  
Date Received05/11/1995
Decision Date 09/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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