Question 1

Who is the manufacturer of UNITED WOUND COVERING, PACKAGE OF 5?

Accepted Answer

United Medical filed the 510(k) submission for UNITED WOUND COVERING, PACKAGE OF 5 (K863389).

Question 2

What is the FDA product code for UNITED WOUND COVERING, PACKAGE OF 5?

Accepted Answer

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

Question 3

When was UNITED WOUND COVERING, PACKAGE OF 5 cleared by the FDA?

Accepted Answer

Nov 17, 1986 (decision: SN).

Question 4

What is the regulatory pathway for UNITED WOUND COVERING, PACKAGE OF 5?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like UNITED WOUND COVERING, PACKAGE OF 5?

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	K863389
Device Name	UNITED WOUND COVERING, PACKAGE OF 5
Applicant	United Medical
Product Code	FRO · SU
Decision Date	Nov 17, 1986
Decision	SN
Submission Type	Traditional
Device Class	Class U

UNITED WOUND COVERING, PACKAGE OF 5

Device Facts