The following data is part of a premarket notification filed by Mizuho America, Inc. with the FDA for Sugita Avm Microclip.
Device ID | K960037 |
510k Number | K960037 |
Device Name: | SUGITA AVM MICROCLIP |
Classification | Clip, Aneurysm |
Applicant | MIZUHO AMERICA, INC. 123 BRIMBAL AVE. Beverly, MA 01915 |
Contact | Lisa A Schweitzer |
Correspondent | Lisa A Schweitzer MIZUHO AMERICA, INC. 123 BRIMBAL AVE. Beverly, MA 01915 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-03 |
Decision Date | 1997-02-05 |
Summary: | summary |