Sepp Adhesive Remover
FDA 510(k) K934790 · Medi-Flex Hospital Products, Inc.
510(k) numberK934790
Submission
- Device name
- Sepp Adhesive Remover
- Applicant
- Medi-Flex Hospital Products, Inc.
Overland Park, KS, US - Received
- October 5, 1993
- Decision date
- March 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K895293 | Kemi Labs - Adhesive Bandage RemoverKOX · Traditional | Kemi Labs, Inc. | 02/09/1990SE |
| K893603 | Remove Adhesive RemoverKOX · Traditional | Smith & Nephew United, Inc. | 07/14/1989SE |
| K881359 | Decalcifying Solution IIKOX · Traditional | Stephens Scientific | 04/19/1988SE |
More from Stephens Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | 05/09/1997SE |
| K962740 | Dermistick Sepp APPLICATOR(200 CT)/(40 CT) 260640/260641KMF · Traditional | 09/06/1996SE |
| K952201 | Port-A-Cath Access KitFMF · Traditional | 10/04/1995SE |
| K952416 | Tracheostomy Care KitBTO · Traditional | 08/09/1995SESK |
| K952256 | Picc Line KitFOZ · Traditional | 07/31/1995SE |
| K952007 | Adherol Sepp ApplicatorFRO · Traditional | 06/08/1995SE |
| K923516 | Compound Benzoin Tincture Usp SeppKMF · Traditional | 01/25/1994SE |
| K920399 | Compound Benzoin Tincture Usp FreppKMF · Traditional | 01/25/1994SE |
| K930196 | Cepti-Seal I.V. Prep KitLRS · Traditional | 07/02/1993SEKD |
| K921347 | Cepti-Seal Dressing Change Kit for Venous CatheterMCY · Traditional | 01/08/1993SEKD |
Questions and answers
When was Sepp Adhesive Remover cleared by the FDA?
Sepp Adhesive Remover (K934790) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 157 days after the submission was received.
What is the product code of K934790?
The FDA product code is KOX – Solvent, Adhesive Tape, a Class I (low risk) device regulated under 21 CFR 878.4730.