Kit Pak Dressing Change Tray
FDA 510(k) K941499 · Kit Pak, Inc.
510(k) numberK941499
Submission
- Device name
- Kit Pak Dressing Change Tray
- Applicant
- Kit Pak, Inc.
Elk Grove Village, IL, US - Received
- March 29, 1994
- Decision date
- July 20, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K942959 | Kit Pak Wet Saline DressingFRO · Traditional | 02/14/1995SN |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | 06/01/1994SEKD |
| K934080 | Urinary Drainage BagEYT · Traditional | 05/18/1994SE |
| K931013 | Foley Catheter TrayKNY · Traditional | 08/09/1993SE |
| K923905 | Wound Dressing KitMCY · Traditional | 07/02/1993SEKD |
| K924051 | Kit Pak I.V. Start KitLYY · Traditional | 06/22/1993SEKD |
| K923906 | Foley Insertion TrayKOD · Traditional | 06/22/1993SEKD |
| K922051 | Kit Pak's Flushing KitKOD · Traditional | 06/17/1993SESK |
| K925281 | Kit Pak Urinary Care SuppliesKNY · Traditional | 04/19/1993SESK |
| K900148 | Kit Pak Irrigation TrayEYN · Traditional | 04/23/1990SEKD |
Questions and answers
When was Kit Pak Dressing Change Tray cleared by the FDA?
Kit Pak Dressing Change Tray (K941499) received a 510(k) decision of Unknown on July 20, 1994, 113 days after the submission was received.
What is the product code of K941499?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.