Kemi Labs - Adhesive Bandage Remover
FDA 510(k) K895293 · Kemi Labs, Inc.
510(k) numberK895293
Submission
- Device name
- Kemi Labs - Adhesive Bandage Remover
- Applicant
- Kemi Labs, Inc.
Milford, CT, US - Received
- August 25, 1989
- Decision date
- February 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOX – Solvent, Adhesive Tape
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4730
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934790 | Sepp Adhesive RemoverKOX · Traditional | Medi-Flex Hospital Products, Inc. | 03/11/1994SE |
| K931933 | Chad Labs Adhesive Bandage RemoverKOX · Traditional | Chad Labs Corp. | 07/08/1993SE |
| K924976 | Allkare(Tm) Adhesive Remover WipeKOX · Traditional | Convatec, A Division of E.R. Squibb & Sons | 04/20/1993SE |
| K924571 | Medi-SolKOX · Traditional | Orange-Sol, Inc. | 04/06/1993SE |
| K925618 | 3M Remover Lotion Product Number 86XXKOX · Traditional | 3M Health Care, Ltd. | 03/31/1993SE |
| K923351 | Skin Support Prep PadKOX · Traditional | Coloplast Corp. | 09/14/1992SE |
| K915150 | Remove Adhesive RemoverKOX · Traditional | Smith & Nephew United, Inc. | 01/09/1992SE |
| K902009 | Elantec's Surgical Tape RemoverKOX · Traditional | Elantec, Inc. | 08/29/1990SE |
| K893603 | Remove Adhesive RemoverKOX · Traditional | Smith & Nephew United, Inc. | 07/14/1989SE |
| K881359 | Decalcifying Solution IIKOX · Traditional | Stephens Scientific | 04/19/1988SE |
Questions and answers
When was Kemi Labs - Adhesive Bandage Remover cleared by the FDA?
Kemi Labs - Adhesive Bandage Remover (K895293) received a 510(k) decision of Substantially Equivalent on February 9, 1990, 168 days after the submission was received.
What is the product code of K895293?
The FDA product code is KOX – Solvent, Adhesive Tape, a Class I (low risk) device regulated under 21 CFR 878.4730.