510(k) K881216 ยท HED Douche Apparatus, Vaginal, Therapeutic
GENT-L-KARE VAGINAL IRRIGATION SET
| Applicant | Geneva Laboratories, Inc., Elkhorn WI, US |
| Decision | Substantially Equivalent, Jun 7, 1988 |
| Received | Mar 22, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881216
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.