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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K031077
Device Name VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
Applicant
Chattanooga Group
4717 Adams Rd.
Hixson,  TN  37343
Applicant Contact CHERYL L BAGWELL
Correspondent
Chattanooga Group
4717 Adams Rd.
Hixson,  TN  37343
Correspondent Contact CHERYL L BAGWELL
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZI   GZJ   HCC   IPF   LIH  
Date Received04/04/2003
Decision Date 12/11/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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