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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
Predetermined Change
Control Plan Authorized		 No
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