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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 K011338
Device Name OTO-CEM
Applicant
Ototech, Inc.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Applicant Contact MICHAEL G FARROW
Correspondent
Ototech, Inc.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Correspondent Contact MICHAEL G FARROW
Regulation Number872.3275
Classification Product Code
NEA  
Date Received05/02/2001
Decision Date 09/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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