Question 1

Who is the manufacturer of WOUND DRESSING?

Accepted Answer

Les Laboratorires Brothier, S.A. filed the 510(k) submission for WOUND DRESSING (K922540).

Question 2

What is the FDA product code for WOUND DRESSING?

Accepted Answer

KMF. It is classified under 21 CFR 880.5090 as a Class 1 device in the General Hospital panel.

Question 3

When was WOUND DRESSING cleared by the FDA?

Accepted Answer

Aug 24, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for WOUND DRESSING?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like 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	K922540
Device Name	WOUND DRESSING
Applicant	Les Laboratorires Brothier, S.A.
Product Code	KMF · General Hospital
Decision Date	Aug 24, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5090
Device Class	Class 1

WOUND DRESSING

Device Facts

Regulatory Classification

Identification