E2550 REUSABLE HANDSWITCHING PENCIL

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E2550 Reusable Handswitching Pencil.

Pre-market Notification Details

Device IDK942183
510k NumberK942183
Device Name:E2550 REUSABLE HANDSWITCHING PENCIL
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
ContactPeggy Walline
CorrespondentPeggy Walline
VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-04
Decision Date1994-05-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884524001913 K942183 000
10884524001593 K942183 000

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