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 |