FDA 510(k)

PHASIX PLUG AND PATCH

K-Number: K120728 · 2012-10-22

Decision Date2012-10-22

Product CodeOWT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PHASIX PLUG AND PATCH is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2012-10-22 under 510(k) number K120728. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASIX PLUG AND PATCH?

PHASIX PLUG AND PATCH is a medical device that received FDA 510(k) clearance on 2012-10-22. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K120728.

When did PHASIX PLUG AND PATCH receive FDA 510(k) clearance?

PHASIX PLUG AND PATCH received FDA 510(k) clearance on 2012-10-22, under 510(k) number K120728.

Who is the listed applicant for PHASIX PLUG AND PATCH?

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

What is the FDA product code for PHASIX PLUG AND PATCH?

The FDA product code for PHASIX PLUG AND PATCH is OWT.

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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.