510(k) K861490 ยท KEM Agent, Clearing
PERMACLEAR SOLUTION CAT. NO. 4950
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, May 6, 1986 |
| Received | Apr 22, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861490
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.