510(k) K884713 ยท FFP Dilator, Rectal
COLONIC BALLOON DIALATORS
| Applicant | Primrose Medical, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Sep 29, 1989 |
| Received | Nov 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884713
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.