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FDA 510(k)

10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE

K-Number: K034031 · 2004-01-21

ApplicantM.K. Meditech Co. , Ltd.
Decision Date2004-01-21
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is M.K. Meditech Co. , Ltd.. It received FDA 510(k) clearance on 2004-01-21 under 510(k) number K034031. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE?

10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2004-01-21. The listed applicant is M.K. Meditech Co. , Ltd.. The 510(k) number is K034031.

When did 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE receive FDA 510(k) clearance?

10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE received FDA 510(k) clearance on 2004-01-21, under 510(k) number K034031.

Who is the listed applicant for 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE?

The FDA 510(k) record lists M.K. Meditech Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE?

The FDA product code for 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE is MEG.

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 M.K. Meditech Co. , 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.

K050131INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGEK031594BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAYK022806DUOPRO SAFETY SYRINGE (DUOPROSS)K020623DUOPRO SAFETY SYRINGE (DUOPROSS)

Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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