The following data is part of a premarket notification filed by Mizuho America, Inc. with the FDA for Sugita Titanium Aneurysm Clip.
| Device ID | K990202 |
| 510k Number | K990202 |
| Device Name: | SUGITA TITANIUM ANEURYSM CLIP |
| Classification | Clip, Aneurysm |
| Applicant | MIZUHO AMERICA, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T.whit Athey |
| Correspondent | T.whit Athey MIZUHO AMERICA, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-06-04 |
| Summary: | summary |