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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, Disposable
510(k) Number K870832
Device Name OXY-THERM
Applicant
M.D. Intl., Inc.
808 A The Strand
Hermosa Beach,  CA  90254
Applicant Contact MARK DAVIS
Correspondent
M.D. Intl., Inc.
808 A The Strand
Hermosa Beach,  CA  90254
Correspondent Contact MARK DAVIS
Regulation Number890.5710
Classification Product Code
IMD  
Date Received03/03/1987
Decision Date 03/12/1987
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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