Mefix(R) Adhesive Fabric for Dressing Fixation
FDA 510(k) K932743 · Scott Health Care
510(k) numberK932743
Submission
- Device name
- Mefix(R) Adhesive Fabric for Dressing Fixation
- Applicant
- Scott Health Care
Fort Worth, TX, US - Received
- June 8, 1993
- Decision date
- September 10, 1993
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K954275 | Mepore Plus (9X15CM)KMF · Traditional | 12/27/1995SE |
| K954274 | Mepore (6X7)KMF · Traditional | 12/19/1995SE |
| K945206 | Alldress Multi Layered Wound DressingKMF · Traditional | 01/12/1995SE |
| K905439 | Hypergel Protective Wound GelKMF · Traditional | 05/29/1991SE |
| K910857 | Alldress Multi Layered Wound DressingNAB · Traditional | 04/12/1991SE |
| K905438 | Normlgel Protective Wound GelFRO · Traditional | 04/01/1991SE |
| K900421 | Promise Absorbent Protective PadHHD · Traditional | 06/06/1990SE |
| K897142 | Mesalt Sterile DressingFRO · Traditional | 03/27/1990SE |
Questions and answers
When was Mefix(R) Adhesive Fabric for Dressing Fixation cleared by the FDA?
Mefix(R) Adhesive Fabric for Dressing Fixation (K932743) received a 510(k) decision of Substantially Equivalent on September 10, 1993, 94 days after the submission was received.
What is the product code of K932743?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.