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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K900356
Device Name THERMOAIRE SPLINT (TM) (TAS)
Applicant
Life Enhancement Technologies, LLC
Medical & Radiation Technology
6319 Massachusetts Ave.
Bethesda,  MD  20816
Applicant Contact ROGER SCHNEIDER
Correspondent
Life Enhancement Technologies, LLC
Medical & Radiation Technology
6319 Massachusetts Ave.
Bethesda,  MD  20816
Correspondent Contact ROGER SCHNEIDER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received01/25/1990
Decision Date 05/07/1990
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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