The following data is part of a premarket notification filed by Gimmi Gmbh with the FDA for Gimmi Aneurysm Clips And Applying Forceps.
Device ID | K081640 |
510k Number | K081640 |
Device Name: | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS |
Classification | Clip, Aneurysm |
Applicant | GIMMI GMBH ONE SCANLAN PLAZA Saint Paul, MN 55107 |
Contact | Ken Blake |
Correspondent | Ken Blake GIMMI GMBH ONE SCANLAN PLAZA Saint Paul, MN 55107 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-11 |
Decision Date | 2009-05-06 |
Summary: | summary |