Coverlet Adhesive Dressing
FDA 510(k) K940378 · Beiersdorf, Inc.
510(k) numberK940378
Submission
- Device name
- Coverlet Adhesive Dressing
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- January 26, 1994
- Decision date
- July 29, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
More from Johnson & Johnson Consumer Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…DWL · Traditional | 12/18/2009SE |
| K032463 | Curad Silver BandageFRO · Traditional | 02/10/2004SE |
| K032462 | Curad Silver Active Gel BandageFRO · Traditional | 02/10/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | 06/18/2003SE |
| K022645 | CuradKMF · Traditional | 11/05/2002SE |
| K952526 | Cutinova CavityKMF · Traditional | 08/14/1995SN |
| K943363 | Cutiplast SterilMGP · Traditional | 03/15/1995SE |
| K944581 | Cutinova Thin Wound DressingKMF · Traditional | 12/02/1994SN |
| K935630 | NortaEZL · Traditional | 10/07/1994SE |
| K925630 | Elastoplast Heat PlasterIRT · Traditional | 02/25/1994SE |
Questions and answers
When was Coverlet Adhesive Dressing cleared by the FDA?
Coverlet Adhesive Dressing (K940378) received a 510(k) decision of Substantially Equivalent for Some Indications on July 29, 1994, 184 days after the submission was received.
What is the product code of K940378?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.