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FDA 510(k)

MODIFICATION TO ZENIEVA

K-Number: K082865 · 2008-10-23

ApplicantGorbec Pharmaceutical Services, Inc.
Decision Date2008-10-23
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ZENIEVA is the device name listed in this FDA 510(k) record. The listed applicant is Gorbec Pharmaceutical Services, Inc.. It received FDA 510(k) clearance on 2008-10-23 under 510(k) number K082865. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ZENIEVA?

MODIFICATION TO ZENIEVA is a medical device that received FDA 510(k) clearance on 2008-10-23. The listed applicant is Gorbec Pharmaceutical Services, Inc.. The 510(k) number is K082865.

When did MODIFICATION TO ZENIEVA receive FDA 510(k) clearance?

MODIFICATION TO ZENIEVA received FDA 510(k) clearance on 2008-10-23, under 510(k) number K082865.

Who is the listed applicant for MODIFICATION TO ZENIEVA?

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

What is the FDA product code for MODIFICATION TO ZENIEVA?

The FDA product code for MODIFICATION TO ZENIEVA is NAE.

Related Clinical Trials

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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Other records listing Gorbec 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.

K100839BARIREPK073246ZENIEVA

Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical ProductsK971597COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)Coloplast Corp.

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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