Leukosport(Tm) Adhesive Tape
FDA 510(k) K894367 · Beiersdorf, Inc.
510(k) numberK894367
Submission
- Device name
- Leukosport(Tm) Adhesive Tape
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- July 14, 1989
- Decision date
- November 15, 1989
- 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
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|---|---|---|---|
| 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 |
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| 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 |
| K940378 | Coverlet Adhesive DressingKGX · Traditional | 07/29/1994SN |
Questions and answers
When was Leukosport(Tm) Adhesive Tape cleared by the FDA?
Leukosport(Tm) Adhesive Tape (K894367) received a 510(k) decision of Substantially Equivalent for Some Indications on November 15, 1989, 124 days after the submission was received.
What is the product code of K894367?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.