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FDA 510(k)

DISPOSABLE SYRINGES & NEEDLES

K-Number: K854563 · 1985-12-09

ApplicantMedelec Intl. Corp.
Decision Date1985-12-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SYRINGES & NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K854563. 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 DISPOSABLE SYRINGES & NEEDLES?

DISPOSABLE SYRINGES & NEEDLES is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K854563.

When did DISPOSABLE SYRINGES & NEEDLES receive FDA 510(k) clearance?

DISPOSABLE SYRINGES & NEEDLES received FDA 510(k) clearance on 1985-12-09, under 510(k) number K854563.

Who is the listed applicant for DISPOSABLE SYRINGES & NEEDLES?

The FDA 510(k) record lists Medelec Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SYRINGES & NEEDLES?

The FDA product code for DISPOSABLE SYRINGES & NEEDLES is FMF.

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Other records listing Medelec Intl. Corp. 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.

K961013DISPOSABLE NEEDLE ELECTRODEK935017TD50 ELECTROMYOGRAPHK922548MEDELEC 2110 AND 2114 EEGK920127ELECTROENCEPHALOGRAPH RECORDING SYSTEMK912775SAPPHIRE 4ME EMG/EP SYSTEMK865106PROPHYLACTIC (CONDOM) MR. JOHNNY

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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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