Epi-Lock Wound Dressing
FDA 510(k) K926034 · Calgon Vestal Div.
510(k) numberK926034
Submission
- Device name
- Epi-Lock Wound Dressing
- Applicant
- Calgon Vestal Div.
St. Louis, MO, US - Received
- December 1, 1992
- Decision date
- April 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944494 | Alsa-KlenzFLG · Traditional | 10/19/1994SE |
| K944033 | Bill Evans-KlenzFLG · Traditional | 10/07/1994SE |
| K942270 | Saf-Gel Hydrating Dermal Wound DressingKMF · Traditional | 08/04/1994SE |
| K931477 | AmerseLRJ · Traditional | 06/17/1994SE |
| K931816 | Vesta-Syde(R) Interim Instr Decontamination SystemLRJ · Traditional | 05/26/1994SE |
| K931342 | LPHLRJ · Traditional | 05/26/1994SE |
| K941163 | Mon-KlenzFLG · Traditional | 05/18/1994SE |
| K931573 | Vesphene IILRJ · Traditional | 05/16/1994SE |
| K932277 | Lonza Formulation R-82LRJ · Traditional | 05/12/1994SE |
| K931599 | Hydrasorb Sterile DressingMGP · Traditional | 07/08/1993SE |
Questions and answers
When was Epi-Lock Wound Dressing cleared by the FDA?
Epi-Lock Wound Dressing (K926034) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 140 days after the submission was received.
What is the product code of K926034?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.