NON-CORING HUBER TYPE NEEDLES

Needle, Hypodermic, Single Lumen

ADVANTAGE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Non-coring Huber Type Needles.

Pre-market Notification Details

Device IDK873957
510k NumberK873957
Device Name:NON-CORING HUBER TYPE NEEDLES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham,  PA  19044
ContactJoel A Marcus
CorrespondentJoel A Marcus
ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham,  PA  19044
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-28
Decision Date1987-10-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38498840008721 K873957 000
58498840006820 K873957 000
58498840006813 K873957 000
30849884001717 K873957 000
30849884001434 K873957 000
30849884006552 K873957 000
30849884006545 K873957 000
30849884006538 K873957 000
30849884006507 K873957 000
58498840006837 K873957 000
38498840006840 K873957 000
38498840006857 K873957 000
38498840006949 K873957 000
38498840006932 K873957 000
58498840006929 K873957 000
38498840006918 K873957 000
58498840006905 K873957 000
38498840006895 K873957 000
58498840006882 K873957 000
58498840006868 K873957 000
30849884006484 K873957 000

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