Dermatec Zone Transparent Dressing

FDA 510(k) K863578 · Dermatec, Inc.

Substantially Equivalent for Some Indications

510(k) numberK863578

Submission

Device name
Dermatec Zone Transparent Dressing
Applicant
Dermatec, Inc.
Trumbull, CT, US
Received
August 28, 1986
Decision date
November 25, 1986
Decision
Substantially Equivalent for Some Indications (SN)
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

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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
K863580Dermatec Transparent Film DressingNAD · Traditional 12/31/1986SN
K863379Dermatec Burn PadsNAD · Traditional 09/26/1986SN
K833638Dermatex Sterile Finger BandageNAD · Traditional 12/27/1983SE

Questions and answers

When was Dermatec Zone Transparent Dressing cleared by the FDA?

Dermatec Zone Transparent Dressing (K863578) received a 510(k) decision of Substantially Equivalent for Some Indications on November 25, 1986, 89 days after the submission was received.

What is the product code of K863578?

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