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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K833839
Device Name BIOTHERM
Applicant
Trileen, Inc.
Costa Mesa,  CA  92627
Applicant Contact Frederic Ouweleen
Correspondent
Trileen, Inc.
Costa Mesa,  CA  92627
Correspondent Contact Frederic Ouweleen
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received11/03/1983
Decision Date 12/27/1983
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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