The following data is part of a premarket notification filed by Innova Corp. with the FDA for Innova Telescopic Distractor.
| Device ID | K984117 |
| 510k Number | K984117 |
| Device Name: | INNOVA TELESCOPIC DISTRACTOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | INNOVA CORP. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein INNOVA CORP. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-17 |
| Decision Date | 1999-02-10 |
| Summary: | summary |