510(k) K012374 ยท GBM Catheter, Urethral
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
| Applicant | Astra Tech, Inc., Northborough MA, US |
| Decision | Substantially Equivalent, Aug 23, 2001 |
| Received | Jul 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012374
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.