510(k) K013243 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
| Applicant | Bioform, Inc., Franksville WI, US |
| Decision | Substantially Equivalent, Jan 9, 2002 |
| Received | Sep 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2015 | Merz North America, Inc. PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency. Terminated |
KHJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.