SUBCUTANEOUS INFUSION SET

Set, Administration, Intravascular

MARQUETTE MEDICAL, INC.

The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Subcutaneous Infusion Set.

Pre-market Notification Details

Device IDK920537
510k NumberK920537
Device Name:SUBCUTANEOUS INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton,  MD  21114
ContactMarquette Jr.
CorrespondentMarquette Jr.
MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton,  MD  21114
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-05
Decision Date1992-10-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852323007323 K920537 000
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00852323007200 K920537 000
00852323007194 K920537 000
00852323007187 K920537 000
00852323007002 K920537 000

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