The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-line Graft, Reinforcing, Mini Aneurysm Clip.
Device ID | K091921 |
510k Number | K091921 |
Device Name: | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP |
Classification | Clip, Aneurysm |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Paul Amaral |
Correspondent | Paul Amaral Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-30 |
Decision Date | 2009-09-08 |
Summary: | summary |