The following data is part of a premarket notification filed by Acme-monaco Corp. with the FDA for Acme Preformed Coated Ligature Ties (tooth Shade).
| Device ID | K895854 |
| 510k Number | K895854 |
| Device Name: | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | ACME-MONACO CORP. P.O. BOX 264 Plainville, CT 06052 |
| Contact | Herbert M Carter |
| Correspondent | Herbert M Carter ACME-MONACO CORP. P.O. BOX 264 Plainville, CT 06052 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1990-04-09 |