Vari/Moist Wound Dressing

FDA 510(k) K896358 · Catalina Biomedical Corp.

Substantially Equivalent for Some Indications

510(k) numberK896358

Submission

Device name
Vari/Moist Wound Dressing
Applicant
Catalina Biomedical Corp.
Duarte, CA, US
Received
November 6, 1989
Decision date
February 1, 1990
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KGX – Tape And Bandage, Adhesive
Device class
Class I (low risk)
Regulation
21 CFR 880.5240
Specialty
General Hospital

Other 510(k)s with product code KGX

510(k)DeviceApplicantDecision
K001240Seragard Injection PatchKGX · Traditional Platinum Services, Inc.06/21/2000SE
K983368Care Band Antibacterial BandagesKGX · Traditional Aso Corp.02/17/1999SE
K972914Syvek PatchKGX · Traditional Marine Polymer Technologies, Inc.12/22/1997SE
K943314Adhesive Bandages with OTC DrugKGX · Traditional Johnson & Johnson Consumer Products, Inc.01/17/1996SE
K952606Targett PatchKGX · Traditional Cutting Edge Technologies, Inc.12/21/1995SE
K954007ParallelKGX · Traditional Johnson & Johnson Consumer Products, Inc.11/22/1995SE
K944587Dermiview Hypoallergenic Clear TapeKGX · Traditional Johnson & Johnson Medical, Inc.10/30/1995SE
K944588Sterile Plastic DressingKGX · Traditional Smith & Nephew, Inc.11/07/1994SE
K941788Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional Johnson & Johnson Consumer Products, Inc.10/03/1994SE
K940536Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional Johnson & Johnson Consumer Products, Inc.10/03/1994SE

More from Johnson & Johnson Consumer Products, Inc.

510(k)DeviceDecision
K920050Biolex Wound Gel,MGQ · Traditional 04/07/1992SN
K913480Wound Care Tray aMCY · Traditional 10/18/1991SE
K913479Wound Care Tray BMCY · Traditional 10/08/1991SE
K896421Transparent Film I.V. Site/Wound DressingKMK · Traditional 01/31/1990SE

Questions and answers

When was Vari/Moist Wound Dressing cleared by the FDA?

Vari/Moist Wound Dressing (K896358) received a 510(k) decision of Substantially Equivalent for Some Indications on February 1, 1990, 87 days after the submission was received.

What is the product code of K896358?

The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.