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FDA 510(k) Application Details - K171232
Device Classification Name
Bronchoscope Accessory
More FDA Info for this Device
510(K) Number
K171232
Device Name
Bronchoscope Accessory
Applicant
Olympus Surgical Technologies America
136 Turnpike Road
Southborough, MA 01772-2104 US
Other 510(k) Applications for this Company
Contact
Mary Anne Patella
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
KTI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2017
Decision Date
09/21/2017
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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