The following data is part of a premarket notification filed by Chemlink Laboratories Llc. with the FDA for Microstat 2.
Device ID | K984485 |
510k Number | K984485 |
Device Name: | MICROSTAT 2 |
Classification | Disinfectant, Medical Devices |
Applicant | CHEMLINK LABORATORIES LLC. 122 C STREET, N.W., SUITE 740 Washington, DC 20001 |
Contact | Kari E Mavian |
Correspondent | Kari E Mavian CHEMLINK LABORATORIES LLC. 122 C STREET, N.W., SUITE 740 Washington, DC 20001 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-17 |
Decision Date | 1999-01-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROSTAT 2 75056547 2141365 Live/Registered |
Septodont, Inc. 1996-02-12 |