510(k) K971901 ยท KNT Tubes, Gastrointestinal (And Accessories)
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
| Applicant | Radius Intl., Inc., Tarpon Springs FL, US |
| Decision | Substantially Equivalent, Jan 22, 1998 |
| Received | May 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971901
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.