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FDA 510(k)

RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

K-Number: K001017 · 2000-06-02

ApplicantRetrax Safety Systems, Inc.
Decision Date2000-06-02
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC is the device name listed in this FDA 510(k) record. The listed applicant is Retrax Safety Systems, Inc.. It received FDA 510(k) clearance on 2000-06-02 under 510(k) number K001017. 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 RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC?

RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC is a medical device that received FDA 510(k) clearance on 2000-06-02. The listed applicant is Retrax Safety Systems, Inc.. The 510(k) number is K001017.

When did RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC receive FDA 510(k) clearance?

RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC received FDA 510(k) clearance on 2000-06-02, under 510(k) number K001017.

Who is the listed applicant for RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC?

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

What is the FDA product code for RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC?

The FDA product code for RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC is MEG.

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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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