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FDA 510(k)

NOVAGUARD, MODEL 3611001

K-Number: K082908 · 2009-04-24

ApplicantWest Pharmaceutical Services, Inc.
Decision Date2009-04-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NOVAGUARD, MODEL 3611001 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 2009-04-24 under 510(k) number K082908. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAGUARD, MODEL 3611001?

NOVAGUARD, MODEL 3611001 is a medical device that received FDA 510(k) clearance on 2009-04-24. The listed applicant is West Pharmaceutical Services, Inc.. The 510(k) number is K082908.

When did NOVAGUARD, MODEL 3611001 receive FDA 510(k) clearance?

NOVAGUARD, MODEL 3611001 received FDA 510(k) clearance on 2009-04-24, under 510(k) number K082908.

Who is the listed applicant for NOVAGUARD, MODEL 3611001?

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, MODEL 3611001?

The FDA product code for NOVAGUARD, MODEL 3611001 is FMI.

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Related Devices (Code: FMI)

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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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