HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

Hysteroscope (and Accessories)

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Hf Resection Electrode, Loop W/runner Hyster/acces.

Pre-market Notification Details

Device IDK931764
510k NumberK931764
Device Name:HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
ClassificationHysteroscope (and Accessories)
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-08
Decision Date1994-06-08

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