Who is the manufacturer of CONVATEC ABSORBENT BANDAGE?

Convatec, A Division of E.R. Squibb & Sons filed the 510(k) submission for CONVATEC ABSORBENT BANDAGE (K904233).

What is the FDA product code for CONVATEC ABSORBENT BANDAGE?

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

What is the regulatory pathway for CONVATEC ABSORBENT BANDAGE?

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

Who can help prepare an FDA 510(k) submission like CONVATEC ABSORBENT BANDAGE?

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.

CONVATEC ABSORBENT BANDAGE

K904233 · Convatec, A Division of E.R. Squibb & Sons · EXE · Mar 6, 1991 · Gastroenterology, Urology

Device Facts

Record ID	K904233
Device Name	CONVATEC ABSORBENT BANDAGE
Applicant	Convatec, A Division of E.R. Squibb & Sons
Product Code	EXE · Gastroenterology, Urology
Decision Date	Mar 6, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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