The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Collins Radioparent Sternal Blades.
| Device ID | K904352 |
| 510k Number | K904352 |
| Device Name: | CODMAN COLLINS RADIOPARENT STERNAL BLADES |
| Classification | Blade, Saw, Surgical, Cardiovascular |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Jeanette Cloutier |
| Correspondent | Jeanette Cloutier Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | DWH |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1990-11-21 |