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FDA 510(k) Application Details - K191102
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K191102
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
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Contact
Jessie Duong
Other 510(k) Applications for this Contact
Regulation Number
874.4760
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Classification Product Code
EOB
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More FDA Info for this Product Code
Date Received
04/25/2019
Decision Date
09/06/2019
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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