The following data is part of a premarket notification filed by Kerr Corp. with the FDA for Take One Bite Modified.
| Device ID | K010994 |
| 510k Number | K010994 |
| Device Name: | TAKE ONE BITE MODIFIED |
| Classification | Material, Impression |
| Applicant | KERR CORP. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell KERR CORP. 1717 WEST COLLINS AVE. 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 | 2001-04-03 |
| Decision Date | 2001-04-23 |