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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 K862286
Device Name ARTHROPHONOMETER
Applicant
ARTHROTEK, INC.
30 SHERMAN ST.
WEST HARTFORD,  CT  06110
Applicant Contact JOHN S HALL
Correspondent
ARTHROTEK, INC.
30 SHERMAN ST.
WEST HARTFORD,  CT  06110
Correspondent Contact JOHN S HALL
Regulation Number872.2050
Classification Product Code
NFQ  
Subsequent Product Code
NFS  
Date Received06/16/1986
Decision Date 01/07/1987
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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