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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 K931608
Device Name NCA-200
Applicant
Ics Medical Corp.
2227 Hammond Dr.
Schaumburg,  IL  60173
Applicant Contact DELMAR F BLOEM
Correspondent
Ics Medical Corp.
2227 Hammond Dr.
Schaumburg,  IL  60173
Correspondent Contact DELMAR F BLOEM
Regulation Number874.1800
Classification Product Code
KHH  
Date Received04/01/1993
Decision Date 06/22/1993
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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