Deseret Catheter Dressing
FDA 510(k) K812073 · Warner-Lambert Co.
510(k) numberK812073
Submission
- Device name
- Deseret Catheter Dressing
- Applicant
- Warner-Lambert Co.
Mchenry, IL, US - Received
- July 21, 1981
- Decision date
- October 6, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K001240 | Seragard Injection PatchKGX · Traditional | Platinum Services, Inc. | 06/21/2000SE |
| K983368 | Care Band Antibacterial BandagesKGX · Traditional | Aso Corp. | 02/17/1999SE |
| K972914 | Syvek PatchKGX · Traditional | Marine Polymer Technologies, Inc. | 12/22/1997SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 01/17/1996SE |
| K952606 | Targett PatchKGX · Traditional | Cutting Edge Technologies, Inc. | 12/21/1995SE |
| K954007 | ParallelKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 11/22/1995SE |
| K944587 | Dermiview Hypoallergenic Clear TapeKGX · Traditional | Johnson & Johnson Medical, Inc. | 10/30/1995SE |
| K944588 | Sterile Plastic DressingKGX · Traditional | Smith & Nephew, Inc. | 11/07/1994SE |
| K941788 | Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
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| K870584 | O.P.T.(Tm) Ovulation Prediction TestCEP · Traditional | 11/25/1987SE |
| K861510 | Multilumen Viapic Central Line CatheterFOZ · Traditional | 06/09/1986SE |
| K852967 | General Diagnostics' Ceftriaxone 30MCG Susdep DiskJTN · Traditional | 08/19/1985SE |
| K852689 | General Diagnostics Ceftazidime 30 MCG Susc DiskJTN · Traditional | 08/19/1985SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | 08/13/1985SE |
| K852889 | General Diagnostics Rapid E. Coli TestJTO · Traditional | 07/23/1985SE |
| K850486 | General Diag. Chromostrate Heparin AssayKFF · Traditional | 05/08/1985SE |
| K850412 | Gen. Diag. Chromostrate Antithrombin III AssayJBQ · Traditional | 05/08/1985SE |
Questions and answers
When was Deseret Catheter Dressing cleared by the FDA?
Deseret Catheter Dressing (K812073) received a 510(k) decision of Substantially Equivalent on October 6, 1981, 77 days after the submission was received.
What is the product code of K812073?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.