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FDA 510(k)

UNIQUE NEEDLE WITH FIRM GRIP SHIELD

K-Number: K950666 · 1996-02-16

ApplicantUnique Management Ent., Inc.
Decision Date1996-02-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIQUE NEEDLE WITH FIRM GRIP SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Unique Management Ent., Inc.. It received FDA 510(k) clearance on 1996-02-16 under 510(k) number K950666. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIQUE NEEDLE WITH FIRM GRIP SHIELD?

UNIQUE NEEDLE WITH FIRM GRIP SHIELD is a medical device that received FDA 510(k) clearance on 1996-02-16. The listed applicant is Unique Management Ent., Inc.. The 510(k) number is K950666.

When did UNIQUE NEEDLE WITH FIRM GRIP SHIELD receive FDA 510(k) clearance?

UNIQUE NEEDLE WITH FIRM GRIP SHIELD received FDA 510(k) clearance on 1996-02-16, under 510(k) number K950666.

Who is the listed applicant for UNIQUE NEEDLE WITH FIRM GRIP SHIELD?

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

What is the FDA product code for UNIQUE NEEDLE WITH FIRM GRIP SHIELD?

The FDA product code for UNIQUE NEEDLE WITH FIRM GRIP SHIELD is FMF.

Related Clinical Trials

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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Other records listing Unique Management Ent., Inc. as applicant

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.

K950245UNIQUE NEEDLE

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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