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FDA 510(k)

EXTRICARE 100CC/ 250CC/ 400CC CANISTERS

K-Number: K132252 · 2013-09-27

ApplicantDevon Medical
Decision Date2013-09-27
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXTRICARE 100CC/ 250CC/ 400CC CANISTERS is the device name listed in this FDA 510(k) record. The listed applicant is Devon Medical. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K132252. 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 100CC/ 250CC/ 400CC CANISTERS?

EXTRICARE 100CC/ 250CC/ 400CC CANISTERS is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Devon Medical. The 510(k) number is K132252.

When did EXTRICARE 100CC/ 250CC/ 400CC CANISTERS receive FDA 510(k) clearance?

EXTRICARE 100CC/ 250CC/ 400CC CANISTERS received FDA 510(k) clearance on 2013-09-27, under 510(k) number K132252.

Who is the listed applicant for EXTRICARE 100CC/ 250CC/ 400CC CANISTERS?

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

What is the FDA product code for EXTRICARE 100CC/ 250CC/ 400CC CANISTERS?

The FDA product code for EXTRICARE 100CC/ 250CC/ 400CC CANISTERS 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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