The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Maxilla (le Fort) Distraction System.
| Device ID | K982604 |
| 510k Number | K982604 |
| Device Name: | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Diana Preston |
| Correspondent | Diana Preston WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1998-10-23 |
| Summary: | summary |