Who is the manufacturer of DRAINING-WOUND MGMT. SYSTEM?

Johnson & Johnson Professionals, Inc. filed the 510(k) submission for DRAINING-WOUND MGMT. SYSTEM (K810812).

What is the FDA product code for DRAINING-WOUND MGMT. SYSTEM?

EXB. It is classified under 21 CFR 876.5900 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for DRAINING-WOUND MGMT. SYSTEM?

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

Who can help prepare an FDA 510(k) submission like DRAINING-WOUND MGMT. SYSTEM?

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.

DRAINING-WOUND MGMT. SYSTEM

K810812 · Johnson & Johnson Professionals, Inc. · EXB · Apr 17, 1981 · Gastroenterology, Urology

Device Facts

Record ID	K810812
Device Name	DRAINING-WOUND MGMT. SYSTEM
Applicant	Johnson & Johnson Professionals, Inc.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Apr 17, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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