The following data is part of a premarket notification filed by Inrad with the FDA for Ultraclip Ii Mr.
| Device ID | K041201 |
| 510k Number | K041201 |
| Device Name: | ULTRACLIP II MR |
| Classification | Staple, 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 | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-07 |
| Decision Date | 2004-06-03 |