510(k) K010448 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
| Applicant | Horizons Intl. Corp., Ponce PR, US |
| Decision | Substantially Equivalent, May 16, 2001 |
| Received | Feb 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010448
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.