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FDA 510(k)

EXTRICARE

K-Number: K110078 · 2012-02-10

ApplicantDevon Medical Products, Inc.
Decision Date2012-02-10
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXTRICARE is the device name listed in this FDA 510(k) record. The listed applicant is Devon Medical Products, Inc.. It received FDA 510(k) clearance on 2012-02-10 under 510(k) number K110078. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRICARE?

EXTRICARE is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Devon Medical Products, Inc.. The 510(k) number is K110078.

When did EXTRICARE receive FDA 510(k) clearance?

EXTRICARE received FDA 510(k) clearance on 2012-02-10, under 510(k) number K110078.

Who is the listed applicant for EXTRICARE?

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

What is the FDA product code for EXTRICARE?

The FDA product code for EXTRICARE is OMP.

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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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