Tielle Plus Hydropolymer Adhesive Dressing
FDA 510(k) K983234 · Johnson & Johnson Medical, Div. of Ethicon, Inc.
510(k) numberK983234
Submission
- Device name
- Tielle Plus Hydropolymer Adhesive Dressing
- Applicant
- Johnson & Johnson Medical, Div. of Ethicon, Inc.
Arlington, TX, US - Received
- September 15, 1998
- Decision date
- November 25, 1998
- 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 |
|---|---|---|
| K990236 | Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters…FOZ · Traditional | 08/20/1999SE |
| K990395 | Barrier Surgical GownsFYA · Traditional | 04/13/1999SE |
| K983240 | Neutralon PF Powder Free Brown Latex Surgical GlovesKGO · Traditional | 11/30/1998SE |
| K983394 | Modification to Tielle Hydropolmer DressingMGP · Traditional | 11/03/1998SE |
Questions and answers
When was Tielle Plus Hydropolymer Adhesive Dressing cleared by the FDA?
Tielle Plus Hydropolymer Adhesive Dressing (K983234) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 71 days after the submission was received.
What is the product code of K983234?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.