The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Dumbach Titanium Mesh Implant System.
Device ID | K862532 |
510k Number | K862532 |
Device Name: | DUMBACH TITANIUM MESH IMPLANT SYSTEM |
Classification | Plate, Bone |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Debra A Powers |
Correspondent | Debra A Powers WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-02 |
Decision Date | 1986-09-05 |