The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Surgicalplaster Calcium Sulface Hemihydrate.
| Device ID | K051381 |
| 510k Number | K051381 |
| Device Name: | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-27 |
| Decision Date | 2005-07-15 |
| Summary: | summary |