The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Invotec Poly-mesh Mandibular Tray.
| Device ID | K901923 |
| 510k Number | K901923 |
| Device Name: | INVOTEC POLY-MESH MANDIBULAR TRAY |
| Classification | Prosthesis, Facial, Mandibular Implant |
| Applicant | INVOTEC INTERNATIONAL, INC. 11330-1ST. JOHN'S INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 11330-1ST. JOHN'S INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Product Code | JAZ |
| CFR Regulation Number | 874.3695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-10-31 |