The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Take 1 Advanced Rigid Tray.
| Device ID | K092176 |
| 510k Number | K092176 |
| Device Name: | TAKE 1 ADVANCED RIGID TRAY |
| Classification | Material, Impression |
| Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2010-01-28 |
| Summary: | summary |