The following data is part of a premarket notification filed by Bioform, Inc. with the FDA for Calcium Hydroxylapatite Implant, Icc And 0.5cc, Models 8038-3, 8037-3.
| Device ID | K030682 |
| 510k Number | K030682 |
| Device Name: | CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIOFORM, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Contact | William G Hubbard |
| Correspondent | William G Hubbard BIOFORM, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-05 |
| Decision Date | 2003-06-27 |
| Summary: | summary |