Targett Patch
FDA 510(k) K952606 · Cutting Edge Technologies, Inc.
510(k) numberK952606
Submission
- Device name
- Targett Patch
- Applicant
- Cutting Edge Technologies, Inc.
Malvern, PA, US - Received
- June 6, 1995
- Decision date
- December 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K940798 | Shippert Pressure BandageKGX · Traditional | Denver Splint Co. | 09/28/1994SE |
More from Denver Splint Co.
| 510(k) | Device | Decision |
|---|---|---|
| K963595 | Seragard Vascular Access DeviceFMI · Traditional | 01/06/1997SE |
Questions and answers
When was Targett Patch cleared by the FDA?
Targett Patch (K952606) received a 510(k) decision of Substantially Equivalent on December 21, 1995, 198 days after the submission was received.
What is the product code of K952606?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.