Band-Aid Brand Adhesive Bandages, Sport Strip
FDA 510(k) K941788 · Johnson & Johnson Consumer Products, Inc.
510(k) numberK941788
Submission
- Device name
- Band-Aid Brand Adhesive Bandages, Sport Strip
- Applicant
- Johnson & Johnson Consumer Products, Inc.
North Brunswick, NJ, US - Received
- April 11, 1994
- Decision date
- October 3, 1994
- 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 |
| 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 |
| 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 |
|---|---|---|
| K071710 | Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)IMD · Traditional | 08/14/2007SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | 01/17/1996SE |
| K954007 | ParallelKGX · Traditional | 11/22/1995SE |
| K951917 | Johnson & Johnson Easy Slide Dental FlossJES · Traditional | 05/10/1995SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | 10/03/1994SE |
| K935440 | Johnson & Johnson Fluoride Dental Floss, Mint WaxedJES · Traditional | 02/03/1994SE |
| K840679 | Serenity Contoured Absorbent ShieldsEYQ · Traditional | 03/22/1984SE |
Questions and answers
When was Band-Aid Brand Adhesive Bandages, Sport Strip cleared by the FDA?
Band-Aid Brand Adhesive Bandages, Sport Strip (K941788) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 175 days after the submission was received.
What is the product code of K941788?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.