The following data is part of a premarket notification filed by Micrylium Laboratories with the FDA for Bio-2000.
Device ID | K973765 |
510k Number | K973765 |
Device Name: | BIO-2000 |
Classification | Unit, Operative Dental |
Applicant | MICRYLIUM LABORATORIES 1755 WEST UNIVERSITY DR. SUITE 118 Temple, AZ 85281 |
Contact | Thad J Overmyer, Dmd |
Correspondent | Thad J Overmyer, Dmd MICRYLIUM LABORATORIES 1755 WEST UNIVERSITY DR. SUITE 118 Temple, AZ 85281 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-02 |
Decision Date | 1998-11-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BIO-2000 75138324 2148297 Dead/Cancelled |
NATURE'S BODYCARE N.A., INC. 1996-07-23 |