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FDA 510(k)

PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE

K-Number: K063755 · 2007-02-27

ApplicantSmiths Medical Asd, Inc.
Decision Date2007-02-27
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2007-02-27 under 510(k) number K063755. 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 PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE?

PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE is a medical device that received FDA 510(k) clearance on 2007-02-27. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K063755.

When did PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE receive FDA 510(k) clearance?

PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE received FDA 510(k) clearance on 2007-02-27, under 510(k) number K063755.

Who is the listed applicant for PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE?

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

What is the FDA product code for PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE?

The FDA product code for PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE 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

View on FDA Database →

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

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