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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Fluidotherapy
510(k) Number K011243
Device Name CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
Applicant
CHATTANOOGA GROUP, INC.
4717 ADAMS RD.
HIXSON,  TN  37343
Applicant Contact CHERYL L BAGWELL
Correspondent
CHATTANOOGA GROUP, INC.
4717 ADAMS RD.
HIXSON,  TN  37343
Correspondent Contact CHERYL L BAGWELL
Regulation Number890.5100
Classification Product Code
LSB  
Date Received04/23/2001
Decision Date 07/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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