Sterile Burnnet Pre-Cut (Various Sizes)

FDA 510(k) K891459 · Western Medical, Ltd.

Substantially Equivalent

510(k) numberK891459

Submission

Device name
Sterile Burnnet Pre-Cut (Various Sizes)
Applicant
Western Medical, Ltd.
Camarillo, CA, US
Received
March 15, 1989
Decision date
May 26, 1989
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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K043063Oxyband Wound DressingNAD · Traditional Oxyband Technologies, Inc.03/24/2005SE
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K990530Kerlix MD Antimicrobial Gauze DressingNAD · Traditional The Kendall Company, L.P.01/31/2000SE
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Questions and answers

When was Sterile Burnnet Pre-Cut (Various Sizes) cleared by the FDA?

Sterile Burnnet Pre-Cut (Various Sizes) (K891459) received a 510(k) decision of Substantially Equivalent on May 26, 1989, 72 days after the submission was received.

What is the product code of K891459?

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