VALLEYLAB SUCTION COAGULATOR, MODEL E3305

Electrosurgical, Cutting & Coagulation & Accessories

COVIDIEN LP

The following data is part of a premarket notification filed by Covidien Lp with the FDA for Valleylab Suction Coagulator, Model E3305.

Pre-market Notification Details

Device IDK091223
510k NumberK091223
Device Name:VALLEYLAB SUCTION COAGULATOR, MODEL E3305
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant COVIDIEN LP 5920 LONGBOW DR. Boulder,  CO  80301
ContactPhilip Ake
CorrespondentPhilip Ake
COVIDIEN LP 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-27
Decision Date2009-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889942016235 K091223 000
10884521039094 K091223 000
10884521039070 K091223 000
10884521039100 K091223 000
10884521039087 K091223 000
20884521039091 K091223 000
20884521039077 K091223 000

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