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FDA 510(k)

MODIFICATION TO ZENIEVA

K-Number: K083721 · 2009-01-08

ApplicantRiver'S Edge Pharmaceuticals, LLC
Decision Date2009-01-08
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 River'S Edge Pharmaceuticals, LLC. It received FDA 510(k) clearance on 2009-01-08 under 510(k) number K083721. 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 2009-01-08. The listed applicant is River'S Edge Pharmaceuticals, LLC. The 510(k) number is K083721.

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

MODIFICATION TO ZENIEVA received FDA 510(k) clearance on 2009-01-08, under 510(k) number K083721.

Who is the listed applicant for MODIFICATION TO ZENIEVA?

The FDA 510(k) record lists River'S Edge Pharmaceuticals, LLC 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.

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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.

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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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