SURGITRON MODEL FFPF-EMC

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 Model Ffpf-emc.

Pre-market Notification Details

Device IDK972072
510k NumberK972072
Device Name:SURGITRON MODEL FFPF-EMC
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 Received1997-06-03
Decision Date1997-06-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494104900 K972072 000
00841494104894 K972072 000

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