510(k) K935642 ยท FPK Tubing, Fluid Delivery
EVANS MEDICAL EXTENSION SETS
| Applicant | Evans Medical, Inc., Pineville PA, US |
| Decision | Substantially Equivalent, Jan 28, 1994 |
| Received | Nov 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global Sta Terminated |
FPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.