The following data is part of a premarket notification filed by Transcendencias Comerciales Sl Transcom with the FDA for Hc-1 And Hc-1 Classic.
| Device ID | K131852 |
| 510k Number | K131852 |
| Device Name: | HC-1 AND HC-1 CLASSIC |
| Classification | Colonic Irrigation System |
| Applicant | TRANSCENDENCIAS COMERCIALES SL TRANSCOM C/ZUBIBERRI 31- PLANTA BAJA LOCAL 1 San Sebastian, Guipuzcoa, ES 20018 |
| Contact | Ramon Echevarria |
| Correspondent | Ramon Echevarria TRANSCENDENCIAS COMERCIALES SL TRANSCOM C/ZUBIBERRI 31- PLANTA BAJA LOCAL 1 San Sebastian, Guipuzcoa, ES 20018 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2014-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B482Z201 | K131852 | 000 |
| B482Z171 | K131852 | 000 |
| B482Z161 | K131852 | 000 |
| B482Z101 | K131852 | 000 |
| B482Z091 | K131852 | 000 |
| B482HC1C1 | K131852 | 000 |
| B482HC11 | K131852 | 000 |