Who is the manufacturer of DUODERM FLEXIBLE HYDROACTIVE DRESSINGS?

Convatec, A Division of E.R. Squibb & Sons filed the 510(k) submission for DUODERM FLEXIBLE HYDROACTIVE DRESSINGS (K841287).

What is the FDA product code for DUODERM FLEXIBLE HYDROACTIVE DRESSINGS?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for DUODERM FLEXIBLE HYDROACTIVE DRESSINGS?

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

Who can help prepare an FDA 510(k) submission like DUODERM FLEXIBLE HYDROACTIVE DRESSINGS?

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.

DUODERM FLEXIBLE HYDROACTIVE DRESSINGS

K841287 · Convatec, A Division of E.R. Squibb & Sons · FRO · Aug 20, 1984 · SU

Device Facts

Record ID	K841287
Device Name	DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
Applicant	Convatec, A Division of E.R. Squibb & Sons
Product Code	FRO · SU
Decision Date	Aug 20, 1984
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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