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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-Air
510(k) Number K950785
Device Name HORTMANN AIRMATIC AIR CALORIC STIMULATOR
Applicant
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Applicant Contact CRAIG R PARKS
Correspondent
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Correspondent Contact CRAIG R PARKS
Regulation Number874.1800
Classification Product Code
KHH  
Date Received02/21/1995
Decision Date 06/28/1995
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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