510(k) K173004 ยท FDS Gastroscope And Accessories, Flexible/Rigid
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
| Applicant | Sumitomo Bakelite Co., Ltd., Shinagawa-Ku, JP |
| Decision | Substantially Equivalent, May 8, 2018 |
| Received | Sep 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173004
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.