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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K861383
Device Name SOLEX THERAPEUTIC PAD
Applicant
Intl. Diathermics Research, Inc.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Intl. Diathermics Research, Inc.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number890.5740
Classification Product Code
IRT  
Date Received04/14/1986
Decision Date 04/18/1986
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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