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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 K153009
Device Name ULTRA Telescopes
Applicant
OLYMPUS, WINTER & IBE GMBH
KUEHNSTR. 61
Hamburg,  DE 22045
Applicant Contact Katharina Schnackenburg
Correspondent
OLYMPUS CORPORATION OF THE AMERICAS
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034
Correspondent Contact Sheri L. Musgnung
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/14/2015
Decision Date 04/05/2016
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
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