510(k) K131852 ยท KPL Colonic Irrigation System
HC-1 AND HC-1 CLASSIC
| Applicant | Transcendencias Comerciales SL Transcom, San Sebastian, Guipuzcoa, ES |
| Decision | Substantially Equivalent, Apr 17, 2014 |
| Received | Jun 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131852
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.