PERCUTANEOUS GRAINAGE CATHETER

Catheter, Nephrostomy

MENLO CARE, INC.

The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Percutaneous Grainage Catheter.

Pre-market Notification Details

Device IDK943893
510k NumberK943893
Device Name:PERCUTANEOUS GRAINAGE CATHETER
ClassificationCatheter, Nephrostomy
Applicant MENLO CARE, INC. 1350 WILLOW RD. Menlo Park,  CA  94025 -1516
ContactBob Bley
CorrespondentBob Bley
MENLO CARE, INC. 1350 WILLOW RD. Menlo Park,  CA  94025 -1516
Product CodeLJE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-09
Decision Date1995-03-07

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