The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Intraoral Distraction System.
| Device ID | K990944 |
| 510k Number | K990944 |
| Device Name: | OSTEOMED INTRAORAL DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
| Contact | Rick A Buss |
| Correspondent | Rick A Buss OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-22 |
| Decision Date | 1999-06-16 |
| Summary: | summary |