Question 1

Who is the manufacturer of DUODERM(R) HYDROACTIVE(R) PASTE?

Accepted Answer

Convatec, A Division of E.R. Squibb & Sons filed the 510(k) submission for DUODERM(R) HYDROACTIVE(R) PASTE (K881302).

Question 2

What is the FDA product code for DUODERM(R) HYDROACTIVE(R) PASTE?

Accepted Answer

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

Question 3

When was DUODERM(R) HYDROACTIVE(R) PASTE cleared by the FDA?

Accepted Answer

Apr 28, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for DUODERM(R) HYDROACTIVE(R) PASTE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DUODERM(R) HYDROACTIVE(R) PASTE?

Accepted Answer

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.

Record ID	K881302
Device Name	DUODERM(R) HYDROACTIVE(R) PASTE
Applicant	Convatec, A Division of E.R. Squibb & Sons
Product Code	FRO · SU
Decision Date	Apr 28, 1988
Decision	SESE
Submission Type	Traditional
Device Class	Class U

DUODERM(R) HYDROACTIVE(R) PASTE

Device Facts