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FDA 510(k)

COLOPLAST-DURASEAL OSTOMY APPLIANCE

K-Number: K780409 · 1978-04-27

ApplicantC.R. Bard, Inc.
Decision Date1978-04-27
Product CodeEZS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST-DURASEAL OSTOMY APPLIANCE 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 1978-04-27 under 510(k) number K780409. The device is classified under product code EZS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOPLAST-DURASEAL OSTOMY APPLIANCE?

COLOPLAST-DURASEAL OSTOMY APPLIANCE is a medical device that received FDA 510(k) clearance on 1978-04-27. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K780409.

When did COLOPLAST-DURASEAL OSTOMY APPLIANCE receive FDA 510(k) clearance?

COLOPLAST-DURASEAL OSTOMY APPLIANCE received FDA 510(k) clearance on 1978-04-27, under 510(k) number K780409.

Who is the listed applicant for COLOPLAST-DURASEAL OSTOMY APPLIANCE?

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 COLOPLAST-DURASEAL OSTOMY APPLIANCE?

The FDA product code for COLOPLAST-DURASEAL OSTOMY APPLIANCE is EZS.

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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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