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FDA 510(k)

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM

K-Number: K973012 · 1997-11-05

ApplicantMDC Research , Ltd.
Decision Date1997-11-05
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is MDC Research , Ltd.. It received FDA 510(k) clearance on 1997-11-05 under 510(k) number K973012. 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 MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM?

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is MDC Research , Ltd.. The 510(k) number is K973012.

When did MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM receive FDA 510(k) clearance?

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM received FDA 510(k) clearance on 1997-11-05, under 510(k) number K973012.

Who is the listed applicant for MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM?

The FDA 510(k) record lists MDC Research , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM?

The FDA product code for MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM is FMI.

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 MDC Research , Ltd. 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.

K022959SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1K960013MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM

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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