FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)

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 Handset W/laparoscopic Electrode (28cm).

Pre-market Notification Details

Device IDK924918
510k NumberK924918
Device Name:FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)
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 Received1992-09-29
Decision Date1993-01-29

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