The following data is part of a premarket notification filed by Cl Medical with the FDA for I-stop Trans Obturator Male Sling.
| Device ID | K063079 |
| 510k Number | K063079 |
| Device Name: | I-STOP TRANS OBTURATOR MALE SLING |
| Classification | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Applicant | CL MEDICAL 28 AVENUE GENERAL DE GAULLE Sainte Foy Les Lyon, FR F-69110 |
| Contact | Vincent Goria |
| Correspondent | Vincent Goria CL MEDICAL 28 AVENUE GENERAL DE GAULLE Sainte Foy Les Lyon, FR F-69110 |
| Product Code | OTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2006-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760151650239 | K063079 | 000 |