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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841291106043 | K193479 | 000 |
| 10841291105824 | K193479 | 000 |
| 10841291105831 | K193479 | 000 |
| 10841291105855 | K193479 | 000 |
| 10841291105862 | K193479 | 000 |
| 10841291105893 | K193479 | 000 |
| 10841291105909 | K193479 | 000 |
| 10841291105916 | K193479 | 000 |
| 10841291105923 | K193479 | 000 |
| 10841291105930 | K193479 | 000 |
| 10841291105947 | K193479 | 000 |
| 10841291105954 | K193479 | 000 |
| 10841291105961 | K193479 | 000 |
| 10841291105978 | K193479 | 000 |
| 10841291106005 | K193479 | 000 |
| 10841291106012 | K193479 | 000 |
| 10841291106029 | K193479 | 000 |
| 10841291106036 | K193479 | 000 |
| 10841291105794 | K193479 | 000 |