BML SERIES

Lithotriptor, Biliary Mechanical

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Bml Series.

Pre-market Notification Details

Device IDK903529
510k NumberK903529
Device Name:BML SERIES
ClassificationLithotriptor, Biliary Mechanical
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactDaniel J Dillon
CorrespondentDaniel J Dillon
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeLQC  
CFR Regulation Number876.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-06
Decision Date1991-01-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170218446 K903529 000
14953170032988 K903529 000
04953170032967 K903529 000
04953170032943 K903529 000
14953170032872 K903529 000
04953170032851 K903529 000
04953170032837 K903529 000
14953170032766 K903529 000
14953170032742 K903529 000
04953170033001 K903529 000
04953170033025 K903529 000
14953170218429 K903529 000
14953170218412 K903529 000
14953170218399 K903529 000
14953170218382 K903529 000
14953170218368 K903529 000
14953170218344 K903529 000
04953170033247 K903529 000
14953170033077 K903529 000
04953170032721 K903529 000

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