510(k) K851188 ยท FKT System, Dialysate Delivery, Sorbent Regenerated
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
| Applicant | Organon Teknika Corp., Oklahoma City OK, US |
| Decision | Substantially Equivalent, Apr 12, 1985 |
| Received | Feb 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851188
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.