FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22

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 System Model No. Gsu-20 And Gsu-22.

Pre-market Notification Details

Device IDK942579
510k NumberK942579
Device Name:FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
ContactCharles M Copperberg
CorrespondentCharles M Copperberg
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 Received1994-05-31
Decision Date1994-09-21

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