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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 K132009
Device Name CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
Applicant
SCHOELLY FIBEROPTIC, GMBH
5 WHITCOMB AVE.
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU, RAC
Correspondent
SCHOELLY FIBEROPTIC, GMBH
5 WHITCOMB AVE.
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU, RAC
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/01/2013
Decision Date 04/09/2014
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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