SUGITRON MODEL: IEC

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 Sugitron Model: Iec.

Pre-market Notification Details

Device IDK980177
510k NumberK980177
Device Name:SUGITRON MODEL: IEC
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 Received1998-01-20
Decision Date1998-07-07

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