The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Man Surg Instr/access Dumbach Titan Mesh Impl Sys.
| Device ID | K862523 |
| 510k Number | K862523 |
| Device Name: | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS |
| Classification | Broach, Endodontic |
| 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 | EKW |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-02 |
| Decision Date | 1986-08-01 |