Isopore(Tm) Tape, Modification
FDA 510(k) K925384 · Lectec Corp.
510(k) numberK925384
Submission
- Device name
- Isopore(Tm) Tape, Modification
- Applicant
- Lectec Corp.
Minnetonka, MN, US - Received
- October 26, 1992
- Decision date
- April 21, 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
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| 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 |
|---|---|---|
| K950943 | Ultra EaseIYO · Traditional | 03/07/1996SE |
| K930258 | Tracet T-6000DRX · Traditional | 04/16/1993SE |
| K923558 | ECG ElectrodeDRX · Traditional | 02/18/1993SE |
| K922959 | Isopore TapeKGX · Traditional | 09/11/1992SE |
| K912450 | Tracets Sme 5000DRX · Traditional | 08/28/1991SE |
| K904512 | Tracet AG 4000DRX · Traditional | 01/31/1991SE |
| K893425 | VitatraceDRX · Traditional | 07/14/1989SE |
| K884108 | Macropore Medical/Surgical Paper TapeKGX · Traditional | 11/10/1988SN |
| K882216 | Syncor (R) Model S-801 ECG ElectrodeDRX · Traditional | 07/20/1988SE |
| K881872 | TENS Electrode Model 238PGXY · Traditional | 06/16/1988SE |
Questions and answers
When was Isopore(Tm) Tape, Modification cleared by the FDA?
Isopore(Tm) Tape, Modification (K925384) received a 510(k) decision of Substantially Equivalent on April 21, 1993, 177 days after the submission was received.
What is the product code of K925384?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.