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FDA 510(k)

STERILE INSULIN DISPOS. NEEDLE/GREEN

K-Number: K840083 · 1984-02-21

ApplicantLee Medical Intl., Inc.
Decision Date1984-02-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE INSULIN DISPOS. NEEDLE/GREEN is the device name listed in this FDA 510(k) record. The listed applicant is Lee Medical Intl., Inc.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K840083. 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 STERILE INSULIN DISPOS. NEEDLE/GREEN?

STERILE INSULIN DISPOS. NEEDLE/GREEN is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Lee Medical Intl., Inc.. The 510(k) number is K840083.

When did STERILE INSULIN DISPOS. NEEDLE/GREEN receive FDA 510(k) clearance?

STERILE INSULIN DISPOS. NEEDLE/GREEN received FDA 510(k) clearance on 1984-02-21, under 510(k) number K840083.

Who is the listed applicant for STERILE INSULIN DISPOS. NEEDLE/GREEN?

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

What is the FDA product code for STERILE INSULIN DISPOS. NEEDLE/GREEN?

The FDA product code for STERILE INSULIN DISPOS. NEEDLE/GREEN is FMF.

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Other records listing Lee Medical Intl., 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.

K840081IV ADMINISTRATION SETK840082STERILE INSULIN DISPOS. NEEDLE/SYRINGEK832104STERILE DISP. BUTTERFLY INFUSION SETK832105ADMINISTRATIVE IV SETK832101STERILE DISPOSABLE SYRINGEK832102STERILE DISPOSABLE NEEDLES

View all 8 devices →

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

View on FDA Database →

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

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