Question 1

Who is the manufacturer of DUODERM HYDROACTIVE DRESSING W/BORDER STERILE?

Accepted Answer

Convatec, A Division of E.R. Squibb & Sons filed the 510(k) submission for DUODERM HYDROACTIVE DRESSING W/BORDER STERILE (K853844).

Question 2

What is the FDA product code for DUODERM HYDROACTIVE DRESSING W/BORDER STERILE?

Accepted Answer

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

Question 3

When was DUODERM HYDROACTIVE DRESSING W/BORDER STERILE cleared by the FDA?

Accepted Answer

Nov 15, 1985 (decision: SN).

Question 4

What is the regulatory pathway for DUODERM HYDROACTIVE DRESSING W/BORDER STERILE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DUODERM HYDROACTIVE DRESSING W/BORDER STERILE?

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	K853844
Device Name	DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
Applicant	Convatec, A Division of E.R. Squibb & Sons
Product Code	FRO · SU
Decision Date	Nov 15, 1985
Decision	SN
Submission Type	Traditional
Device Class	Class U

DUODERM HYDROACTIVE DRESSING W/BORDER STERILE

Device Facts