The following data is part of a premarket notification filed by Trollplast, Inc. with the FDA for Troll-bite.
| Device ID | K853451 |
| 510k Number | K853451 |
| Device Name: | TROLL-BITE |
| Classification | Holder, Film, X-ray |
| Applicant | TROLLPLAST, INC. P.O. BOX 1703 New Milford, CT 06776 |
| Contact | Gunilla K Horrocks |
| Correspondent | Gunilla K Horrocks TROLLPLAST, INC. P.O. BOX 1703 New Milford, CT 06776 |
| Product Code | EGZ |
| CFR Regulation Number | 872.1905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1986-01-21 |