SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF

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 120 Iec (also Known As Surgitron 4.0 Dual Rf.

Pre-market Notification Details

Device IDK013255
510k NumberK013255
Device Name:SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
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 Received2001-09-28
Decision Date2001-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494108465 K013255 000
00841494108472 K013255 000
00841494106690 K013255 000
00841494104887 K013255 000
00841494104870 K013255 000

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