The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Double Bow Tooth Separator.
| Device ID | K831136 |
| 510k Number | K831136 |
| Device Name: | DOUBLE BOW TOOTH SEPARATOR |
| Classification | Retainer, Matrix |
| Applicant | ALMORE INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEP |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-07 |
| Decision Date | 1983-06-08 |