FDA 510(k)

IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR

K-Number: K910455 · 1991-02-14

Decision Date1991-02-14

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 1991-02-14 under 510(k) number K910455. 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 IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR?

IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR is a medical device that received FDA 510(k) clearance on 1991-02-14. The listed applicant is Ziehm International, Inc.. The 510(k) number is K910455.

When did IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR receive FDA 510(k) clearance?

IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR received FDA 510(k) clearance on 1991-02-14, under 510(k) number K910455.

Who is the listed applicant for IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR?

The FDA 510(k) record lists Ziehm International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR?

The FDA product code for IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR is FMI.

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Other records listing Ziehm International, 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.