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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 K142249
Device Name SCHOELLY SINUSCOPE
Applicant
SCHOELLY FIBEROPTIC GMBH
ROBERT-BOSCH-STR. 1-3
DENZLINGEN,  DE D-79211
Applicant Contact SANDRA BAUMANN
Correspondent
DELPHI MEDICAL DEVICE CONSULTING, INC.
5 WHITCOMB AVE
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/14/2014
Decision Date 01/27/2015
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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