The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Songer(tm) Cable System.
| Device ID | K913735 |
| 510k Number | K913735 |
| Device Name: | SONGER(TM) CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-20 |
| Decision Date | 1991-11-18 |