RESECTOSCOPE SHEATH

Resectoscope

OLYMPUS CORP.

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

Pre-market Notification Details

Device IDK931995
510k NumberK931995
Device Name:RESECTOSCOPE SHEATH
ClassificationResectoscope
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactBarry Sands
CorrespondentBarry Sands
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeFJL  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-23
Decision Date1993-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761004190 K931995 000
04042761004176 K931995 000
04042761001823 K931995 000

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