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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Examining/Treatment, Ent
510(k) Number K823226
Device Name SN-100 DOCTOR'S ROUND
Applicant
KELLS MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KELLS MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.5300
Classification Product Code
ETF  
Date Received10/29/1982
Decision Date 11/22/1982
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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