MANAN BLUNT NEEDLE

Set, Administration, Intravascular

MANAN MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Blunt Needle.

Pre-market Notification Details

Device IDK981386
510k NumberK981386
Device Name:MANAN BLUNT NEEDLE
ClassificationSet, Administration, Intravascular
Applicant MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook,  IL  60062
ContactMichael Plishka
CorrespondentMichael Plishka
MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook,  IL  60062
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-16
Decision Date1998-06-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40195327155569 K981386 000
40198459043872 K981386 000

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