The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Blue Device.
| Device ID | K020407 |
| 510k Number | K020407 |
| Device Name: | LORENZ BLUE DEVICE |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Kim Reed |
| Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-06 |
| Decision Date | 2002-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036157265 | K020407 | 000 |
| 00841036010836 | K020407 | 000 |
| 00841036010843 | K020407 | 000 |
| 00841036010935 | K020407 | 000 |
| 00841036010942 | K020407 | 000 |
| 00841036010959 | K020407 | 000 |
| 00841036057404 | K020407 | 000 |
| 00841036057411 | K020407 | 000 |
| 00841036075309 | K020407 | 000 |
| 00841036092825 | K020407 | 000 |
| 00841036157258 | K020407 | 000 |
| 00841036075217 | K020407 | 000 |