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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Chilling
510(k) Number K871112
Device Name PELTIERTHERAPY(C) HEAT/COLD TREATMENT
Applicant
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Applicant Contact ERNEST J HENLEY
Correspondent
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Correspondent Contact ERNEST J HENLEY
Regulation Number890.5940
Classification Product Code
IMF  
Date Received03/19/1987
Decision Date 05/06/1987
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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