The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Sundt Slim-line Graft Clips.
| Device ID | K912456 |
| 510k Number | K912456 |
| Device Name: | SUNDT SLIM-LINE GRAFT CLIPS |
| Classification | Clip, Aneurysm |
| 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 | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1995-03-10 |