510(k) K971053 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS
| Applicant | International Medical Products, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | Mar 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971053
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.