The following data is part of a premarket notification filed by Medical Biological Sciences, Inc. with the FDA for Mbs Hard Tissue Replacement System.
Device ID | K832509 |
510k Number | K832509 |
Device Name: | MBS HARD TISSUE REPLACEMENT SYSTEM |
Classification | Bone Grafting Material, Synthetic |
Applicant | MEDICAL BIOLOGICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-27 |
Decision Date | 1983-11-29 |