VL2600 HANDSWITCHING PENCIL WITH HOLSTER

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Vl2600 Handswitching Pencil With Holster.

Pre-market Notification Details

Device IDK955109
510k NumberK955109
Device Name:VL2600 HANDSWITCHING PENCIL WITH HOLSTER
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
ContactHerbert W Vinson
CorrespondentHerbert W Vinson
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 Received1995-11-08
Decision Date1995-12-18

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