510(k) K001640 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
BIOSOFT RESIN
| Applicant | Biosoft International Corp., Trenton NJ, US |
| Decision | Substantially Equivalent, Jun 23, 2000 |
| Received | May 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001640
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.