TRIDENT RESECTION ABLATOR

Electrosurgical, Cutting & Coagulation & Accessories

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Trident Resection Ablator.

Pre-market Notification Details

Device IDK033748
510k NumberK033748
Device Name:TRIDENT RESECTION ABLATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Krejci
CorrespondentLaura D Krejci
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-01
Decision Date2003-12-15
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.