Shippert Pressure Bandage

FDA 510(k) K940798 · Denver Splint Co.

Substantially Equivalent

510(k) numberK940798

Submission

Device name
Shippert Pressure Bandage
Applicant
Denver Splint Co.
Englewood, CO, US
Received
February 22, 1994
Decision date
September 28, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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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

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Questions and answers

When was Shippert Pressure Bandage cleared by the FDA?

Shippert Pressure Bandage (K940798) received a 510(k) decision of Substantially Equivalent on September 28, 1994, 218 days after the submission was received.

What is the product code of K940798?

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