SURGITRON IEC II

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 Surgitron Iec Ii.

Pre-market Notification Details

Device IDK001986
510k NumberK001986
Device Name:SURGITRON IEC II
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 Received2000-06-29
Decision Date2000-09-27

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