510(k) K131803 ยท KNY Accessories, Catheter, G-U
GUARDIAN URETHRAL SHEATH
| Applicant | Solace Therapeutics, Farmingham MA, US |
| Decision | Substantially Equivalent, Aug 20, 2013 |
| Received | Jun 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131803
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.