The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec Biobarrier.
| Device ID | K950306 |
| 510k Number | K950306 |
| Device Name: | IMTEC BIOBARRIER |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | IMTEC CORP. 2007 N. COMMERCE P.O. BOX 1562 Ardmore, OK 73402 |
| Contact | E. S Gillespie |
| Correspondent | E. S Gillespie IMTEC CORP. 2007 N. COMMERCE P.O. BOX 1562 Ardmore, OK 73402 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1996-02-06 |