510(k) K010709 ยท MRD Mammary Sizer
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
| Applicant | Mentor Corp., Santa Barbara CA, US |
| Decision | Substantially Equivalent, Apr 23, 2001 |
| Received | Mar 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010709
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2014 | Mentor Texas, LP. EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer
REF 351-3380SZ 380 cc LOT 6830722.
Product Usage:
This product is indicated for single use Terminated |
MRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.