The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Add-on Condyle.
| Device ID | K002790 |
| 510k Number | K002790 |
| Device Name: | ADD-ON CONDYLE |
| Classification | Prosthesis, Condyle, Mandibular, Temporary |
| Applicant | WALTER LORENZ SURGICAL, INC. 11520 TRADEPORT DR. Jacksonville, FL 32218 -2480 |
| Contact | Trevor Byrd |
| Correspondent | Trevor Byrd WALTER LORENZ SURGICAL, INC. 11520 TRADEPORT DR. Jacksonville, FL 32218 -2480 |
| Product Code | NEI |
| CFR Regulation Number | 872.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-07 |
| Decision Date | 2001-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036091507 | K002790 | 000 |
| 00841036009847 | K002790 | 000 |
| 00841036009830 | K002790 | 000 |