510(k) K935548 ยท FHX Jelly, Lubricating, For Transurethral Surgical Instrument
CATHEJELL S STERILE LUBRICATING JELLY
| Applicant | Pharmazeutische Fabrik Montavit GmbH, Wilton CT, US |
| Decision | Substantially Equivalent, Mar 30, 1994 |
| Received | Nov 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935548
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.