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FDA 510(k)

NUVUE COLORMARK9TM) NEEDLE

K-Number: K101312 · 2011-02-04

ApplicantNuvue Therapeutics, Inc.
Decision Date2011-02-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NUVUE COLORMARK9TM) NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Nuvue Therapeutics, Inc.. It received FDA 510(k) clearance on 2011-02-04 under 510(k) number K101312. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVUE COLORMARK9TM) NEEDLE?

NUVUE COLORMARK9TM) NEEDLE is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Nuvue Therapeutics, Inc.. The 510(k) number is K101312.

When did NUVUE COLORMARK9TM) NEEDLE receive FDA 510(k) clearance?

NUVUE COLORMARK9TM) NEEDLE received FDA 510(k) clearance on 2011-02-04, under 510(k) number K101312.

Who is the listed applicant for NUVUE COLORMARK9TM) NEEDLE?

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

What is the FDA product code for NUVUE COLORMARK9TM) NEEDLE?

The FDA product code for NUVUE COLORMARK9TM) NEEDLE is IYN.

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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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