CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MENLO CARE, INC.

The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Centermark(r) Picc Insertion Tray Landmark(r) Midline Catheter Prep Tray.

Pre-market Notification Details

Device IDK945521
510k NumberK945521
Device Name:CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MENLO CARE, INC. 1350 WILLOW RD. Menlo Park,  CA  94025 -1516
ContactThom Lawson
CorrespondentThom Lawson
MENLO CARE, INC. 1350 WILLOW RD. Menlo Park,  CA  94025 -1516
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-10
Decision Date1995-04-06

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