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 |