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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 K863615
Device Name ENTHERMO IRRIGATION UNIT
Applicant
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number874.1800
Classification Product Code
ETP  
Date Received09/16/1986
Decision Date 12/16/1986
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
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