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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 K011768
Device Name THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
Applicant
Thermo-Electric Co.
455 Rt. 30
Imperial,  PA  15126
Applicant Contact LAWRENCE E MADSON
Correspondent
Thermo-Electric Co.
455 Rt. 30
Imperial,  PA  15126
Correspondent Contact LAWRENCE E MADSON
Regulation Number890.5100
Classification Product Code
LSB  
Date Received06/07/2001
Decision Date 08/03/2001
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
Predetermined Change
Control Plan Authorized		 No
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