Wound Dressing Model ZB-6

FDA 510(k) K850076 · Thermedics, Inc.

Substantially Equivalent

510(k) numberK850076

Submission

Device name
Wound Dressing Model ZB-6
Applicant
Thermedics, Inc.
Woburn, MA, US
Received
January 9, 1985
Decision date
April 15, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
NAD – Dressing, Wound, Occlusive
Device class
Class I (low risk)
Regulation
21 CFR 878.4020
Specialty
General, Plastic Surgery

Other 510(k)s with product code NAD

510(k)DeviceApplicantDecision
K254246LT Antibacterial Foam with Silver DressingNAD · Traditional Zhejiang Longterm Medical Technology Co., Ltd.09/10/2026SE
K102403Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional Sam Medical Products03/03/2011SE
K091133Aplion Topical Care SystemNAD · Traditional Aplion Medical,Llc05/20/2009SE
K072560Envela (Hydrohesive Occlusive Dressing)NAD · Traditional Teikoku Pharma USA, Inc.06/17/2008SE
K080524Centurion Sorbaview OTCNAD · Traditional Tri-State Hospital Supply Corp.04/23/2008SE
K060046DermastreamNAD · Traditional Enzysurge , Ltd.02/27/2006SE
K043063Oxyband Wound DressingNAD · Traditional Oxyband Technologies, Inc.03/24/2005SE
K020781Wet ChamberNAD · Traditional Kinetic Concepts, Inc.05/06/2002SE
K990530Kerlix MD Antimicrobial Gauze DressingNAD · Traditional The Kendall Company, L.P.01/31/2000SE
K990861Wound Dressing/Abd Pad, Model #10810NAD · Traditional Hospital Specialty Co.04/12/1999SE

More from Hospital Specialty Co.

510(k)DeviceDecision
K894131Dermaport Vascular Access Device Model No. 50-1000DQY · Traditional 09/26/1989SE
K863128Peritoneal Dialysis CathetersFJS · Traditional 09/09/1986SE
K854966Acute Peritoneal Dialysis CathetersFKO · Traditional 01/09/1986SE

Questions and answers

When was Wound Dressing Model ZB-6 cleared by the FDA?

Wound Dressing Model ZB-6 (K850076) received a 510(k) decision of Substantially Equivalent on April 15, 1985, 96 days after the submission was received.

What is the product code of K850076?

The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.