The following data is part of a premarket notification filed by A&e Medical Corporation with the FDA for Sternal Cable System.
| Device ID | K193479 |
| 510k Number | K193479 |
| Device Name: | Sternal Cable System |
| Classification | Cerclage, Fixation |
| Applicant | A&E Medical Corporation 5206 Asbury Road, PO Box 758 Farmingdale, NJ 07727 |
| Contact | Peter Browne |
| Correspondent | Peter Browne A&E Medical Corporation 5206 Asbury Road, PO Box 758 Farmingdale, NJ 07727 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-03-23 |