510(k) K043241 ยท GBM Catheter, Urethral
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
| Applicant | Astra Tech, Inc., Northborough MA, US |
| Decision | Substantially Equivalent, Dec 23, 2004 |
| Received | Nov 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043241
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.