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FDA 510(k)

PROCEDUR SF SAFETY SYRINGE DEVICE

K-Number: K042487 · 2005-01-21

ApplicantAvanca Medical Devices, Inc.
Decision Date2005-01-21
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROCEDUR SF SAFETY SYRINGE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Avanca Medical Devices, Inc.. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K042487. 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 PROCEDUR SF SAFETY SYRINGE DEVICE?

PROCEDUR SF SAFETY SYRINGE DEVICE is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Avanca Medical Devices, Inc.. The 510(k) number is K042487.

When did PROCEDUR SF SAFETY SYRINGE DEVICE receive FDA 510(k) clearance?

PROCEDUR SF SAFETY SYRINGE DEVICE received FDA 510(k) clearance on 2005-01-21, under 510(k) number K042487.

Who is the listed applicant for PROCEDUR SF SAFETY SYRINGE DEVICE?

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

What is the FDA product code for PROCEDUR SF SAFETY SYRINGE DEVICE?

The FDA product code for PROCEDUR SF SAFETY SYRINGE DEVICE is MEG.

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Other records listing Avanca Medical Devices, 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.

K052075PROCEDUR-10K042486PROCEDUR 10 SYRINGE DEVICE

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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