ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC

Electrosurgical, Cutting & Coagulation & Accessories

ELLMAN INT'L INC.

The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Ellman International Non-ablative Technique For Surgitron Iec.

Pre-market Notification Details

Device IDK082834
510k NumberK082834
Device Name:ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside,  NY  11572 -3625
ContactRick Epstein
CorrespondentRick Epstein
ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside,  NY  11572 -3625
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-26
Decision Date2009-05-07
Summary:summary

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