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 |