The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Sof'wire (tm) Kit.
| Device ID | K915581 |
| 510k Number | K915581 |
| Device Name: | CODMAN SOF'WIRE (TM) KIT |
| Classification | Cerclage, Fixation |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Jeannette Cloutier |
| Correspondent | Jeannette Cloutier Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1992-01-16 |