510(k) K051381 ยท LYC Bone Grafting Material, Synthetic
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
| Applicant | Ace Surgical Supply Co., Inc., Brockton MA, US |
| Decision | Substantially Equivalent, Jul 15, 2005 |
| Received | May 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2010 | Ace Surgical Supply Co., Inc. Calcium Sulfate Hemihydrate 0.5 gram kits. Terminated |
LYC | None listed |
| Jun 16, 2010 | Ace Surgical Supply Co., Inc. Calcium Sulfate Hemihydrate 1.0 gram kits. Terminated |
LYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.