Leukopor(Tm) Surgical Tape
FDA 510(k) K881509 · Beiersdorf, Inc.
510(k) numberK881509
Submission
- Device name
- Leukopor(Tm) Surgical Tape
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- April 11, 1988
- Decision date
- April 22, 1988
- 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
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| 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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| 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 Leukopor(Tm) Surgical Tape cleared by the FDA?
Leukopor(Tm) Surgical Tape (K881509) received a 510(k) decision of Substantially Equivalent on April 22, 1988, 11 days after the submission was received.
What is the product code of K881509?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.