ACE-KYLE DYE INJECTION NEEDLE P/N 14082

Needle, Hypodermic, Single Lumen

TODAY'S MACHINING & DESIGN, INC.

The following data is part of a premarket notification filed by Today's Machining & Design, Inc. with the FDA for Ace-kyle Dye Injection Needle P/n 14082.

Pre-market Notification Details

Device IDK853604
510k NumberK853604
Device Name:ACE-KYLE DYE INJECTION NEEDLE P/N 14082
ClassificationNeedle, Hypodermic, Single Lumen
Applicant TODAY'S MACHINING & DESIGN, INC. 2368 EASTMAN AVE #14 Ventura,  CA  93002
ContactMark Wilson
CorrespondentMark Wilson
TODAY'S MACHINING & DESIGN, INC. 2368 EASTMAN AVE #14 Ventura,  CA  93002
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-28
Decision Date1985-11-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.