The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Songer Wiring System.
| Device ID | K892651 |
| 510k Number | K892651 |
| Device Name: | SONGER WIRING SYSTEM |
| Classification | Wire, Surgical |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Frank M Lewis |
| Correspondent | Frank M Lewis DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Product Code | LRN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978048017 | K892651 | 000 |
| 00673978047775 | K892651 | 000 |
| 20673978047885 | K892651 | 000 |
| 20673978047977 | K892651 | 000 |
| 20673978048004 | K892651 | 000 |
| 00673978047874 | K892651 | 000 |
| 00673978047898 | K892651 | 000 |
| 00673978047904 | K892651 | 000 |
| 00673978047966 | K892651 | 000 |
| 00673978047980 | K892651 | 000 |
| 00673978047997 | K892651 | 000 |
| 00673978047690 | K892651 | 000 |