BISURE LAPAROSCOPIC BIPOLAR FORCEPS

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Bisure Laparoscopic Bipolar Forceps.

Pre-market Notification Details

Device IDK983743
510k NumberK983743
Device Name:BISURE LAPAROSCOPIC BIPOLAR FORCEPS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
ContactJack Rogers
CorrespondentJack Rogers
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 Received1998-10-23
Decision Date1999-01-21
Summary:summary

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