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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K873254
Device Name THERMOWRAP, A/K/A/, THERMAL WRAP
Applicant
Family Sun Tanning
15442 Brookhurst St.
Westminster,  CA  92683
Applicant Contact HAP NGUYEN
Correspondent
Family Sun Tanning
15442 Brookhurst St.
Westminster,  CA  92683
Correspondent Contact HAP NGUYEN
Regulation Number890.5740
Classification Product Code
IRT  
Date Received08/17/1987
Decision Date 12/11/1987
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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