E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E3590, Smoke Evacuation Attchment For Electrosurgical Pencils.

Pre-market Notification Details

Device IDK945260
510k NumberK945260
Device Name:E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
ContactPeggy Walline
CorrespondentPeggy Walline
VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-28
Decision Date1994-11-09

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