Who is the manufacturer of COLOPLAST-DURASEAL OSTOMY APPLIANCE?

C.R. Bard, Inc. filed the 510(k) submission for COLOPLAST-DURASEAL OSTOMY APPLIANCE (K780409).

What is the FDA product code for COLOPLAST-DURASEAL OSTOMY APPLIANCE?

EZS. It is classified under 21 CFR 876.5900 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for COLOPLAST-DURASEAL OSTOMY APPLIANCE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like COLOPLAST-DURASEAL OSTOMY APPLIANCE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COLOPLAST-DURASEAL OSTOMY APPLIANCE

K780409 · C.R. Bard, Inc. · EZS · Apr 27, 1978 · Gastroenterology, Urology

Device Facts

Record ID	K780409
Device Name	COLOPLAST-DURASEAL OSTOMY APPLIANCE
Applicant	C.R. Bard, Inc.
Product Code	EZS · Gastroenterology, Urology
Decision Date	Apr 27, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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