510(k) K962554 ยท KNT Tubes, Gastrointestinal (And Accessories)
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
| Applicant | Abbott Laboratories, Columbus OH, US |
| Decision | Substantially Equivalent, Nov 7, 1997 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Ross Products Division Abbott Laboratories Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and 55602. Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.