The following data is part of a premarket notification filed by Instrumentations Unltd. with the FDA for Dimac Wires.
| Device ID | K910090 |
| 510k Number | K910090 |
| Device Name: | DIMAC WIRES |
| Classification | Lock, Wire, And Ligature, Intraoral |
| Applicant | INSTRUMENTATIONS UNLTD. 108 JAMES ST. P.O. BOX 14 Quakertown, PA 18951 |
| Contact | Charles Kauffman |
| Correspondent | Charles Kauffman INSTRUMENTATIONS UNLTD. 108 JAMES ST. P.O. BOX 14 Quakertown, PA 18951 |
| Product Code | DYX |
| CFR Regulation Number | 872.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-07-25 |