510(k) K984168 ยท FCF Instrument, Biopsy, Mechanical, Gastrointestinal
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, Dec 7, 1999 |
| Received | Nov 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984168
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.