Question 1

Who is the manufacturer of BIOBRANE BRAND TEMPORARY WOUND DRESSING?

Accepted Answer

Woodroof Laboratories, Inc. filed the 510(k) submission for BIOBRANE BRAND TEMPORARY WOUND DRESSING (K790496).

Question 2

What is the FDA product code for BIOBRANE BRAND TEMPORARY WOUND DRESSING?

Accepted Answer

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

Question 3

When was BIOBRANE BRAND TEMPORARY WOUND DRESSING cleared by the FDA?

Accepted Answer

May 3, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for BIOBRANE BRAND TEMPORARY WOUND DRESSING?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like BIOBRANE BRAND TEMPORARY WOUND DRESSING?

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	K790496
Device Name	BIOBRANE BRAND TEMPORARY WOUND DRESSING
Applicant	Woodroof Laboratories, Inc.
Product Code	KGN · SU
Decision Date	May 3, 1979
Decision	SESE
Submission Type	Traditional
Device Class	Class U

BIOBRANE BRAND TEMPORARY WOUND DRESSING

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