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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Heat, Moist
510(k) Number K832803
Device Name STEAM PAK MOIST HEAT
Applicant
Electro-Med Health Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Electro-Med Health Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5730
Classification Product Code
IMA  
Date Received08/18/1983
Decision Date 09/20/1983
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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