The following data is part of a premarket notification filed by Bio-interfaces, Inc. with the FDA for Bii-plast.
| Device ID | K934947 |
| 510k Number | K934947 |
| Device Name: | BII-PLAST |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Contact | John F Kay |
| Correspondent | John F Kay BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-18 |
| Decision Date | 1994-01-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BII-PLAST 74491417 1880358 Dead/Cancelled |
BIO-INTERFACES, INC. 1994-02-16 |