VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Laparoscopic Handswitch/electrodes.

Pre-market Notification Details

Device IDK904560
510k NumberK904560
Device Name:VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
ContactMark Wenzel
CorrespondentMark Wenzel
VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-05
Decision Date1990-12-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884524002009 K904560 000
20884524000555 K904560 000
20884524000562 K904560 000
20884524000579 K904560 000
30884524000583 K904560 000
30884524001948 K904560 000
30884524001955 K904560 000
30884524001962 K904560 000
30884524001979 K904560 000
20884524001989 K904560 000
30884524001993 K904560 000
20884524000432 K904560 000

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