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 |