The following data is part of a premarket notification filed by Perouse Medical with the FDA for Seal One.
| Device ID | K123035 |
| 510k Number | K123035 |
| Device Name: | SEAL ONE |
| Classification | Clamp, Vascular |
| Applicant | Perouse Medical 135, ROUTE NEUVE Irigny, FR 69 540 |
| Contact | Caroline Daurelle |
| Correspondent | Caroline Daurelle Perouse Medical 135, ROUTE NEUVE Irigny, FR 69 540 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-11-28 |
| Summary: | summary |