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FDA 510(k)

DISPOSABLE HYPODERMIC NEEDLES

K-Number: K821529 · 1982-06-09

ApplicantMedcare Disp Products, Inc.
Decision Date1982-06-09
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HYPODERMIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Disp Products, Inc.. It received FDA 510(k) clearance on 1982-06-09 under 510(k) number K821529. 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 DISPOSABLE HYPODERMIC NEEDLES?

DISPOSABLE HYPODERMIC NEEDLES is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Medcare Disp Products, Inc.. The 510(k) number is K821529.

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

DISPOSABLE HYPODERMIC NEEDLES received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821529.

Who is the listed applicant for DISPOSABLE HYPODERMIC NEEDLES?

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

What is the FDA product code for DISPOSABLE HYPODERMIC NEEDLES?

The FDA product code for DISPOSABLE HYPODERMIC NEEDLES is FMI.

Related Clinical Trials

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Other records listing Medcare Disp Products, 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.

K841949DOSE RELEASE OF STERILIZATION LOTSK841405INJECTION CAP OR ADAPTORK840924SYRINGE, PISTON, ARTERIAL BLOOD SAMPLK821528SYRINGE, PISTONK821530SYRINGE IRRIGATING

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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