The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Biocellect.
| Device ID | K010775 |
| 510k Number | K010775 |
| Device Name: | BIOCELLECT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Contact | M.k. Patterson |
| Correspondent | M.k. Patterson IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-14 |
| Decision Date | 2001-06-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOCELLECT 75826915 not registered Dead/Abandoned |
IMTEC Corporation 1999-10-19 |