Cicanet Wound Contact Layer Dressing - 2 X 3 In. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 In. MODEL0
FDA 510(k) K981713 · Smith & Nephew, Inc.
510(k) numberK981713
Submission
- Device name
- Cicanet Wound Contact Layer Dressing - 2 X 3 In. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 In. MODEL0
- Applicant
- Smith & Nephew, Inc.
Largo, FL, US - Received
- May 15, 1998
- Decision date
- July 31, 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
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|---|---|---|---|
| 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 |
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Questions and answers
When was Cicanet Wound Contact Layer Dressing - 2 X 3 In. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 In. MODEL0 cleared by the FDA?
Cicanet Wound Contact Layer Dressing - 2 X 3 In. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 In. MODEL0 (K981713) received a 510(k) decision of Substantially Equivalent on July 31, 1998, 77 days after the submission was received.
What is the product code of K981713?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.