Who is the manufacturer of DURAHESIVE WAFER WITH FLANGE?

Convatec, A Division of E.R. Squibb & Sons filed the 510(k) submission for DURAHESIVE WAFER WITH FLANGE (K855018).

What is the FDA product code for DURAHESIVE WAFER WITH FLANGE?

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

What is the regulatory pathway for DURAHESIVE WAFER WITH FLANGE?

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

Who can help prepare an FDA 510(k) submission like DURAHESIVE WAFER WITH FLANGE?

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.

DURAHESIVE WAFER WITH FLANGE

K855018 · Convatec, A Division of E.R. Squibb & Sons · EXB · Feb 4, 1986 · Gastroenterology, Urology

Device Facts

Record ID	K855018
Device Name	DURAHESIVE WAFER WITH FLANGE
Applicant	Convatec, A Division of E.R. Squibb & Sons
Product Code	EXB · Gastroenterology, Urology
Decision Date	Feb 4, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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