Medical Adhesive Tape & Bandage Using Hytrel Film
FDA 510(k) K870092 · Avery Intl.
510(k) numberK870092
Submission
- Device name
- Medical Adhesive Tape & Bandage Using Hytrel Film
- Applicant
- Avery Intl.
Mentor, OH, US - Received
- January 9, 1987
- Decision date
- February 5, 1987
- 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 |
|---|---|---|
| K870093 | Medical Adhesive Tape & Bandage Using Pcce FilmKGX · Traditional | 02/05/1987SN |
| K870021 | Medical Adhesive Tape and Adhesive BandageKGX · Traditional | 02/05/1987SN |
| K870124 | Surgical Drapes and Accessories Using Pebax FilmKKX · Traditional | 02/04/1987SE |
| K870123 | Surgical Drapes and Accessories Using Pcce FilmKKX · Traditional | 02/04/1987SE |
| K870122 | Surgical Drapes and Accessories Using Hytrel FilmKKX · Traditional | 02/04/1987SE |
| K870091 | IV Securement Device Using Pcce Thermo. FilmKGX · Traditional | 02/04/1987SE |
| K870090 | IV Securement Device Using Hytrel Thermo. FilmKGX · Traditional | 02/04/1987SE |
| K870020 | IV Securement DeviceKGX · Traditional | 02/04/1987SE |
| K862438 | Surgical Drapes and Drape AccessoriesKKX · Traditional | 07/16/1986SN |
| K854464 | IV Securement DevicesFRO · Traditional | 03/03/1986SN |
Questions and answers
When was Medical Adhesive Tape & Bandage Using Hytrel Film cleared by the FDA?
Medical Adhesive Tape & Bandage Using Hytrel Film (K870092) received a 510(k) decision of Substantially Equivalent for Some Indications on February 5, 1987, 27 days after the submission was received.
What is the product code of K870092?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.