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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 K881630
Device Name AUTOMATIC CALORIC IRRIGATION SYSTEM
Applicant
ICS MEDICAL CORP.
2227 HAMMOND DR.
SCHAUMBURG,  IL  60173 -3860
Applicant Contact DELMAR F BLOEM
Correspondent
ICS MEDICAL CORP.
2227 HAMMOND DR.
SCHAUMBURG,  IL  60173 -3860
Correspondent Contact DELMAR F BLOEM
Regulation Number874.1800
Classification Product Code
KHH  
Date Received04/14/1988
Decision Date 06/21/1988
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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