510(k) K813416 ยท GBI Material, External Aesthetic Restoration, Used With Adhesive
EXTERNAL BREAST PROSTHESIS
| Applicant | Surgical Appliance Industries, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 18, 1982 |
| Received | Dec 7, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813416
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.