LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)

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 Landmark Venous Access Drive (additional Sizes).

Pre-market Notification Details

Device IDK883980
510k NumberK883980
Device Name:LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto,  CA  94303
ContactDwayne Hardy
CorrespondentDwayne Hardy
MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto,  CA  94303
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-21
Decision Date1988-12-05

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