510(k) K050112 ยท KPL Colonic Irrigation System
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
| Applicant | Prime Pacific Health Innovations Corporation, North Vancouver, Bc, CA |
| Decision | Substantially Equivalent, Mar 15, 2005 |
| Received | Jan 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050112
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.