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 |