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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diathermy, shortwave, for use in applying therapeutic deep heat
510(k) Number K083433
Device Name INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
Applicant
CHATTANOOGA GROUP
4717 ADAMS RD.
HIXSON,  TN  37343
Applicant Contact MICHAEL TREAS
Correspondent
CHATTANOOGA GROUP
4717 ADAMS RD.
HIXSON,  TN  37343
Correspondent Contact MICHAEL TREAS
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received11/20/2008
Decision Date 03/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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