FDA 510(k)

ACE-KYLE DYE INJECTION NEEDLE P/N 14082

K-Number: K853604 · 1985-11-12

ApplicantToday'S Machining & Design, Inc.

Decision Date1985-11-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ACE-KYLE DYE INJECTION NEEDLE P/N 14082 is the device name listed in this FDA 510(k) record. The listed applicant is Today'S Machining & Design, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K853604. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE-KYLE DYE INJECTION NEEDLE P/N 14082?

ACE-KYLE DYE INJECTION NEEDLE P/N 14082 is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Today'S Machining & Design, Inc.. The 510(k) number is K853604.

When did ACE-KYLE DYE INJECTION NEEDLE P/N 14082 receive FDA 510(k) clearance?

ACE-KYLE DYE INJECTION NEEDLE P/N 14082 received FDA 510(k) clearance on 1985-11-12, under 510(k) number K853604.

Who is the listed applicant for ACE-KYLE DYE INJECTION NEEDLE P/N 14082?

The FDA 510(k) record lists Today'S Machining & Design, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE-KYLE DYE INJECTION NEEDLE P/N 14082?

The FDA product code for ACE-KYLE DYE INJECTION NEEDLE P/N 14082 is FMI.

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Other records listing Today'S Machining & Design, Inc. as applicant

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Related Devices (Code: FMI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.