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FDA 510(k)

NovaGuard SA Pro Safety System

K-Number: K163511 · 2017-02-02

ApplicantWest Pharmaceutical Services, Inc.
Decision Date2017-02-02
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NovaGuard SA Pro Safety System is the device name listed in this FDA 510(k) record. The listed applicant is West Pharmaceutical Services, Inc.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K163511. 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 NovaGuard SA Pro Safety System?

NovaGuard SA Pro Safety System is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is West Pharmaceutical Services, Inc.. The 510(k) number is K163511.

When did NovaGuard SA Pro Safety System receive FDA 510(k) clearance?

NovaGuard SA Pro Safety System received FDA 510(k) clearance on 2017-02-02, under 510(k) number K163511.

Who is the listed applicant for NovaGuard SA Pro Safety System?

The FDA 510(k) record lists West Pharmaceutical Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovaGuard SA Pro Safety System?

The FDA product code for NovaGuard SA Pro Safety System is MEG.

Other records listing West Pharmaceutical Services, 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.

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Related Devices (Code: MEG)

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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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