The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Cicanet Wound Contact Layer Dressing - 2 X 3 In. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 In. Model0.
| Device ID | K981713 |
| 510k Number | K981713 |
| Device Name: | CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
| Contact | Jim G Irvin |
| Correspondent | Jim G Irvin SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-07-31 |
| Summary: | summary |