The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Silkon Titanium Cable System.
| Device ID | K942300 |
| 510k Number | K942300 |
| Device Name: | SILKON TITANIUM CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 250 E. ARAPAHO RD. Richardson, TX 75081 |
| Contact | Mary Briggers |
| Correspondent | Mary Briggers AMERICAN MEDICAL ELECTRONICS, INC. 250 E. ARAPAHO RD. Richardson, TX 75081 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-12 |
| Decision Date | 1995-01-09 |