The following data is part of a premarket notification filed by Promepla Sam with the FDA for Rocamed Rocaus Platinum.
| Device ID | K120160 |
| 510k Number | K120160 |
| Device Name: | ROCAMED ROCAUS PLATINUM |
| Classification | Accessories, Catheter, G-u |
| Applicant | PROMEPLA SAM LE COPORI-9 AVENUE PRINCE ALBERT II Monaco, MC Mc 9800 |
| Contact | Krista Johnson |
| Correspondent | Krista Johnson PROMEPLA SAM LE COPORI-9 AVENUE PRINCE ALBERT II Monaco, MC Mc 9800 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-05-14 |
| Summary: | summary |