Debrisan (Dextranomer) Paste

Q: What is the product code of K800737?

The FDA product code is KOZ – Beads, Hydrophilic, For Wound Exudate Absorption, a Class I (low risk) device regulated under 21 CFR 878.4018.

FDA 510(k) K800737 · Pharmaseal Laboratories

Substantially Equivalent

510(k) numberK800737

Submission

Device name: Debrisan (Dextranomer) Paste
Applicant: Pharmaseal Laboratories
Mchenry, IL, US
Received: April 2, 1980
Decision date: August 4, 1980
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: KOZ – Beads, Hydrophilic, For Wound Exudate Absorption
Device class: Class I (low risk)
Regulation: 21 CFR 878.4018
Specialty: General, Plastic Surgery

Other 510(k)s with product code KOZ

510(k)	Device	Applicant	Decision
K905206	Incare Pinsite DressingKOZ · Traditional	Hollister, Inc.	04/12/1991SE
K905688	Cutinova HydroKOZ · Traditional	Beiersdorf, Inc.	04/01/1991SE
K905069	Iodosorb GelKOZ · Traditional	Perstorp AB C/O Robert Joel Slomoff	01/31/1991SE
K904604	Redi-Release Absorbent DressingKOZ · Traditional	Fountain Pharmaceuticals, Inc.	01/07/1991SE
K903645	Dermasorb Wound Contact Layer DressingKOZ · Traditional	Convatec, A Division of E.R. Squibb & Sons	11/21/1990SE
K896828	Bioclusive(R) Absorbent DressingKOZ · Traditional	Johnson & Johnson International	11/21/1990SE
K904412	Allevyn Dressing Claims ChangeKOZ · Traditional	Smith & Nephew United, Inc.	10/23/1990SN
K901876	Intrasite Cavity Wound Dressing (Label Revision)KOZ · Traditional	Smith & Nephew United, Inc.	06/28/1990SN
K896176	Exusorb(Tm) Dry/Wet DressingKOZ · Traditional	Controlled Therapeutics Corp.	11/24/1989SE
K895354	Intrasite Cavity Wound DressingKOZ · Traditional	Smith & Nephew United, Inc.	11/07/1989SN

More from Smith & Nephew United, Inc.

510(k)	Device	Decision
K801146	Sampling KitCBT · Traditional	06/04/1980SE
K800874	Pelvic Exam TrayHHD · Traditional	05/08/1980SE
K800362	Fluid Dispensing SystemKYX · Traditional	03/12/1980SE
K760469	Cleansing Agent, New Wound (Debrissu)KOZ · Traditional	12/16/1976SE

Questions and answers

When was Debrisan (Dextranomer) Paste cleared by the FDA?

Debrisan (Dextranomer) Paste (K800737) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 124 days after the submission was received.

What is the product code of K800737?

The FDA product code is KOZ – Beads, Hydrophilic, For Wound Exudate Absorption, a Class I (low risk) device regulated under 21 CFR 878.4018.