The following data is part of a premarket notification filed by Promepal Sam with the FDA for Rocatub Ureteral Catheter.
| Device ID | K192183 |
| 510k Number | K192183 |
| Device Name: | RocaTub Ureteral Catheter |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | Promepal Sam 9 Avenue Albert II Monaco, MC 98000 |
| Contact | Mohamed Rekik |
| Correspondent | Mohamed Rekik Promepal Sam 9 Avenue Albert II Monaco, MC 98000 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2020-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700512978053 | K192183 | 000 |
| 03700512977926 | K192183 | 000 |
| 03700512977933 | K192183 | 000 |
| 03700512977940 | K192183 | 000 |
| 03700512977964 | K192183 | 000 |
| 03700512977971 | K192183 | 000 |
| 03700512977988 | K192183 | 000 |
| 03700512977995 | K192183 | 000 |
| 03700512978008 | K192183 | 000 |
| 03700512978015 | K192183 | 000 |
| 03700512978022 | K192183 | 000 |
| 03700512978039 | K192183 | 000 |
| 03700512978046 | K192183 | 000 |
| 03700512977919 | K192183 | 000 |