NEEDLELOK HYPODERMIC NEEDLE PROTECTION

Needle, Hypodermic, Single Lumen

DIASOL, INC.

The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Needlelok Hypodermic Needle Protection.

Pre-market Notification Details

Device IDK011004
510k NumberK011004
Device Name:NEEDLELOK HYPODERMIC NEEDLE PROTECTION
ClassificationNeedle, Hypodermic, Single Lumen
Applicant DIASOL, INC. 13212 RAYMER ST. North Hollywood,  CA  91605
ContactMonica Abeles
CorrespondentMonica Abeles
DIASOL, INC. 13212 RAYMER ST. North Hollywood,  CA  91605
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-04
Decision Date2001-05-24

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