510(k) K922398 ยท FCE Enema Kit
4 SURE TM ENEMA BAG SET
| Applicant | Boston Pacific Medical, Inc., Boston MA, US |
| Decision | Unknown, Jun 17, 1993 |
| Received | May 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922398
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.