BIPOLAR TRIGGER-FLEX PROBE

Electrosurgical, Cutting & Coagulation & Accessories

ELLMAN INTL., INC.

The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Bipolar Trigger-flex Probe.

Pre-market Notification Details

Device IDK003126
510k NumberK003126
Device Name:BIPOLAR TRIGGER-FLEX PROBE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett,  NY  11557
ContactFrank Lin
CorrespondentFrank Lin
ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett,  NY  11557
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-05
Decision Date2001-04-11

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