The following data is part of a premarket notification filed by Inrad with the FDA for Ultraclip Ii Us.
| Device ID | K042341 |
| 510k Number | K042341 |
| Device Name: | ULTRACLIP II US |
| Classification | Marker, Radiographic, Implantable |
| Applicant | INRAD 4375 DONKER COURT S.E. Kentwood, MI 49512 |
| Contact | Melissa Lalomia |
| Correspondent | Melissa Lalomia INRAD 4375 DONKER COURT S.E. Kentwood, MI 49512 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-09-20 |