The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Tricotex Wound Contact Layer Dressing.
| Device ID | K864264 |
| 510k Number | K864264 |
| Device Name: | TRICOTEX WOUND CONTACT LAYER DRESSING |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | SMITH & NEPHEW, INC. 1875 HARSH AVE.S.E. P.O.BOX 550 Massillon, OH 44648 -0550 |
| Contact | Homer Gregory |
| Correspondent | Homer Gregory SMITH & NEPHEW, INC. 1875 HARSH AVE.S.E. P.O.BOX 550 Massillon, OH 44648 -0550 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-29 |
| Decision Date | 1986-12-29 |