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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, dental sonography, for monitoring jaw sounds
510(k) Number K905657
Device Name SONOPAK/QS, SONOPAK
Applicant
BIORESEARCH
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Applicant Contact JOHN RADKE
Correspondent
BIORESEARCH
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Correspondent Contact JOHN RADKE
Regulation Number872.2050
Classification Product Code
NFQ  
Date Received12/17/1990
Decision Date 05/15/1991
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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