The following data is part of a premarket notification filed by Orthogen Corp. with the FDA for Surgiplaster Calcium Sulfate Hemihydrate.
| Device ID | K011403 |
| 510k Number | K011403 |
| Device Name: | SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ORTHOGEN CORP. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan ORTHOGEN CORP. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-09-11 |