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FDA 510(k) Application Details - K143673
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K143673
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
Schoelly Fiberoptic Gmbh
Robert-Bosch-Str. 1-3
Denzlingen 79211 DE
Other 510(k) Applications for this Company
Contact
Dr. Sandra Baumann
Other 510(k) Applications for this Contact
Regulation Number
874.4760
More FDA Info for this Regulation Number
Classification Product Code
EOB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/24/2014
Decision Date
03/04/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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