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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K013591
Device Name XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
Applicant
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/30/2001
Decision Date 12/26/2001
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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