510(k) K060815 ยท MIX System, Vocal Cord Medialization
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
| Applicant | Bioform Medical, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Apr 18, 2006 |
| Received | Mar 27, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2015 | Merz North America, Inc. PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fo Terminated |
MIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.