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FDA 510(k) Application Details - K170285
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K170285
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
National Advanced Endoscopy Devices, Inc.
22134 Sherman Way
Canoga Park, CA 91303 US
Other 510(k) Applications for this Company
Contact
Gayle Butler
Other 510(k) Applications for this Contact
Regulation Number
874.4760
More FDA Info for this Regulation Number
Classification Product Code
EOB
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More FDA Info for this Product Code
Date Received
01/30/2017
Decision Date
08/01/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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