SURGITRON RADIOLASE II

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 Surgitron Radiolase Ii.

Pre-market Notification Details

Device IDK042710
510k NumberK042710
Device Name:SURGITRON RADIOLASE II
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside,  NY  11572 -3625
ContactFrank Lin
CorrespondentFrank Lin
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 Received2004-09-30
Decision Date2005-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494104351 K042710 000
00841494101794 K042710 000
00841494101787 K042710 000

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