510(k) K921800 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
| Applicant | Mill-Rose Laboratory, Mentor OH, US |
| Decision | Substantially Equivalent, Feb 8, 1993 |
| Received | Apr 14, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921800
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.