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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Ear, Nose And Throat
510(k) Number K140644
Device Name PROCEM
Applicant
Ototronix, LLC
4486 Timberline Ct.
St. Paul,  MN  55127
Applicant Contact BERNARD HORWATH
Correspondent
Ototronix, LLC
4486 Timberline Ct.
St. Paul,  MN  55127
Correspondent Contact BERNARD HORWATH
Regulation Number872.3275
Classification Product Code
NEA  
Date Received03/13/2014
Decision Date 06/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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