Bandage

FDA 510(k) K761093 · Paco Pharmaceutical Services, Inc.

Substantially Equivalent

510(k) numberK761093

Submission

Device name
Bandage
Applicant
Paco Pharmaceutical Services, Inc.
Lakewood, NJ, US
Received
November 22, 1976
Decision date
January 6, 1977
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

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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
K865111Charter Hard Contact Lens Cleaning SolutionHPX · Traditional 01/20/1987SE
K863974Charter Laboratories Inc. Lens LubricantHPX · Traditional 11/10/1986SE
K862952Charter Wetting Solution for Hard Contact LensesHPX · Traditional 09/25/1986SE
K843797Sterile Saline SolutionBSY · Traditional 01/18/1985SE
K843796Sterile Water · Traditional 12/10/1984SE

Questions and answers

When was Bandage cleared by the FDA?

Bandage (K761093) received a 510(k) decision of Substantially Equivalent on January 6, 1977, 45 days after the submission was received.

What is the product code of K761093?

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