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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Heating, Powered
510(k) Number K924023
Device Name FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
Applicant
Ferno
70 Weil Way
Wilmington,  OH  45177
Applicant Contact ERIC N BESANKO
Correspondent
Ferno
70 Weil Way
Wilmington,  OH  45177
Correspondent Contact ERIC N BESANKO
Regulation Number890.5950
Classification Product Code
IRQ  
Date Received08/11/1992
Decision Date 04/14/1993
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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