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FDA 510(k)

EASY TOUCH

K-Number: K112789 · 2011-12-23

ApplicantMhc Medical Products, LLC
Decision Date2011-12-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EASY TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Mhc Medical Products, LLC. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K112789. 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 EASY TOUCH?

EASY TOUCH is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Mhc Medical Products, LLC. The 510(k) number is K112789.

When did EASY TOUCH receive FDA 510(k) clearance?

EASY TOUCH received FDA 510(k) clearance on 2011-12-23, under 510(k) number K112789.

Who is the listed applicant for EASY TOUCH?

The FDA 510(k) record lists Mhc Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY TOUCH?

The FDA product code for EASY TOUCH 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 Mhc Medical Products, LLC 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.

K163578EasyTouch Safety Pen Needle

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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