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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K031116
Device Name VECTRA (INTELECT) EPR ULTRASOUND
Applicant
CHATTANOOGA GROUP
4717 ADAMS RD.
P.O. BOX 489
HIXSON,  TN  37343
Applicant Contact MICK DAVIS
Correspondent
CHATTANOOGA GROUP
4717 ADAMS RD.
P.O. BOX 489
HIXSON,  TN  37343
Correspondent Contact MICK DAVIS
Regulation Number890.5300
Classification Product Code
IMI  
Date Received04/08/2003
Decision Date 12/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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