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FDA 510(k)

MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE

K-Number: K073705 · 2008-03-24

ApplicantShandong Qiaopai Group Co., Ltd.
Decision Date2008-03-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Qiaopai Group Co., Ltd.. It received FDA 510(k) clearance on 2008-03-24 under 510(k) number K073705. 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 MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE?

MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 2008-03-24. The listed applicant is Shandong Qiaopai Group Co., Ltd.. The 510(k) number is K073705.

When did MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE receive FDA 510(k) clearance?

MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE received FDA 510(k) clearance on 2008-03-24, under 510(k) number K073705.

Who is the listed applicant for MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE?

The FDA 510(k) record lists Shandong Qiaopai Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE?

The FDA product code for MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE is FMI.

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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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