Single Use Biopsy Forceps FB-456D

Bronchoscope (flexible Or Rigid)

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Biopsy Forceps Fb-456d.

Pre-market Notification Details

Device IDK200397
510k NumberK200397
Device Name:Single Use Biopsy Forceps FB-456D
ClassificationBronchoscope (flexible Or Rigid)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentJonathan Gilbert
Olympus Coprporation Of The Americas 3500 Corporation Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-04-24

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