ACCU-DROP I.V. EXTENSION SET

Set, Administration, Intravascular

LAMTIC, INC.

The following data is part of a premarket notification filed by Lamtic, Inc. with the FDA for Accu-drop I.v. Extension Set.

Pre-market Notification Details

Device IDK923560
510k NumberK923560
Device Name:ACCU-DROP I.V. EXTENSION SET
ClassificationSet, Administration, Intravascular
Applicant LAMTIC, INC. 18 TECHNOLOGY DR., SUITE 138 Irvine,  CA  92718
ContactAlfred M Wu
CorrespondentAlfred M Wu
LAMTIC, INC. 18 TECHNOLOGY DR., SUITE 138 Irvine,  CA  92718
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-17
Decision Date1993-06-17

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