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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Caloric-Water
510(k) Number K800442
Device Name VARIOTHERM
Applicant
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.1800
Classification Product Code
ETP  
Date Received02/28/1980
Decision Date 03/10/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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