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 |