The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Sundt Avm Micro Clip.
Device ID | K902544 |
510k Number | K902544 |
Device Name: | SUNDT AVM MICRO CLIP |
Classification | Applier, Aneurysm Clip |
Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Contact | Donald A Lincoln |
Correspondent | Donald A Lincoln Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Product Code | HCI |
CFR Regulation Number | 882.4175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-06 |
Decision Date | 1990-09-20 |