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FDA 510(k)

GUTTMAN INFUSION NEEDLE

K-Number: K830568 · 1983-10-27

ApplicantCosmetic Sciences, Inc.
Decision Date1983-10-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GUTTMAN INFUSION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cosmetic Sciences, Inc.. It received FDA 510(k) clearance on 1983-10-27 under 510(k) number K830568. 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 GUTTMAN INFUSION NEEDLE?

GUTTMAN INFUSION NEEDLE is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Cosmetic Sciences, Inc.. The 510(k) number is K830568.

When did GUTTMAN INFUSION NEEDLE receive FDA 510(k) clearance?

GUTTMAN INFUSION NEEDLE received FDA 510(k) clearance on 1983-10-27, under 510(k) number K830568.

Who is the listed applicant for GUTTMAN INFUSION NEEDLE?

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

What is the FDA product code for GUTTMAN INFUSION NEEDLE?

The FDA product code for GUTTMAN INFUSION NEEDLE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cosmetic Sciences, 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.

K842756BUTTERFLY II PN INFUSION NEEDLEK833682PRIMARY PIGGYBACK INFUSION SET W/PERMK822603PERMA-SET INFUSION SET

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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