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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
Predetermined Change
Control Plan Authorized		 No
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