TTL Medicated Dressing

FDA 510(k) K914733 · Medimix Products, Inc.

Substantially Equivalent

510(k) numberK914733

Submission

Device name
TTL Medicated Dressing
Applicant
Medimix Products, Inc.
Knoxville, TN, US
Received
October 21, 1991
Decision date
July 1, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K940536Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional Johnson & Johnson Consumer Products, Inc.10/03/1994SE

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Questions and answers

When was TTL Medicated Dressing cleared by the FDA?

TTL Medicated Dressing (K914733) received a 510(k) decision of Substantially Equivalent on July 1, 1992, 254 days after the submission was received.

What is the product code of K914733?

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