FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Force Gsu Tm System And Force Gsu Tm Handset.

Pre-market Notification Details

Device IDK904545
510k NumberK904545
Device Name:FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
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 Received1990-10-04
Decision Date1990-12-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884524002392 K904545 000

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