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FDA 510(k)

SOL-M EXCHANGEABLE NEEDLES

K-Number: K112777 · 2012-02-24

ApplicantSol-Milennium Medical, Inc.
Decision Date2012-02-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOL-M EXCHANGEABLE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Milennium Medical, Inc.. It received FDA 510(k) clearance on 2012-02-24 under 510(k) number K112777. 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 SOL-M EXCHANGEABLE NEEDLES?

SOL-M EXCHANGEABLE NEEDLES is a medical device that received FDA 510(k) clearance on 2012-02-24. The listed applicant is Sol-Milennium Medical, Inc.. The 510(k) number is K112777.

When did SOL-M EXCHANGEABLE NEEDLES receive FDA 510(k) clearance?

SOL-M EXCHANGEABLE NEEDLES received FDA 510(k) clearance on 2012-02-24, under 510(k) number K112777.

Who is the listed applicant for SOL-M EXCHANGEABLE NEEDLES?

The FDA 510(k) record lists Sol-Milennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOL-M EXCHANGEABLE NEEDLES?

The FDA product code for SOL-M EXCHANGEABLE NEEDLES is FMI.

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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