Modified Use of Triangle Bandage Sterile

FDA 510(k) K874161 · K. W. Griffen Co.

Substantially Equivalent

510(k) numberK874161

Submission

Device name
Modified Use of Triangle Bandage Sterile
Applicant
K. W. Griffen Co.
Stamford, CT, US
Received
October 13, 1987
Decision date
December 4, 1987
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

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K091133Aplion Topical Care SystemNAD · Traditional Aplion Medical,Llc05/20/2009SE
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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
K961098Bio-Dressing, Sterile Island DressingMGP · Traditional 05/03/1996SN
K953810Fluff Gauze Bandage, Sterile & Non-SterileEFQ · Traditional 09/14/1995SE
K870258Bioscrub Surgical Scrub BrushGEC · Traditional 02/24/1987SE

Questions and answers

When was Modified Use of Triangle Bandage Sterile cleared by the FDA?

Modified Use of Triangle Bandage Sterile (K874161) received a 510(k) decision of Substantially Equivalent on December 4, 1987, 52 days after the submission was received.

What is the product code of K874161?

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