The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lactosorb Ethmoid Stent.
| Device ID | K002131 |
| 510k Number | K002131 |
| Device Name: | LACTOSORB ETHMOID STENT |
| Classification | Splint, Intranasal Septal |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Trevor Byrd |
| Correspondent | Trevor Byrd WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2001-04-13 |