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FDA 510(k) Application Details - K183654
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K183654
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
PENTAX of America, Inc.
3 Paragon Drive
Montvale, NJ 07645-1782 US
Other 510(k) Applications for this Company
Contact
William Goeller
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2018
Decision Date
05/23/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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