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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K935324
Device Name THERAPEUTIC ULTRASOUND AND STIMULATOR
Applicant
Chattanooga Group, Inc.
4717 Adams Rd.
Hixson,  TN  37343
Applicant Contact GRAHAME R WATTS
Correspondent
Chattanooga Group, Inc.
4717 Adams Rd.
Hixson,  TN  37343
Correspondent Contact GRAHAME R WATTS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/05/1993
Decision Date 05/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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