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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K110326
Device Name OSRAM ITOS
Applicant
Osram Sylvania, Inc.
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Applicant Contact MARIE A SCHROEDER
Correspondent
Osram Sylvania, Inc.
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact MARIE A SCHROEDER
Regulation Number874.4770
Classification Product Code
ERA  
Date Received02/03/2011
Decision Date 10/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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