The following data is part of a premarket notification filed by Inodent with the FDA for Micro 2 System.
Device ID | K900785 |
510k Number | K900785 |
Device Name: | MICRO 2 SYSTEM |
Classification | Attachment, Precision, All |
Applicant | INODENT SUITE 120 CANAL SQUARE 1054 31ST STREET NW WASHINGTON, DC 20007 |
Contact | JEAN-PIERRE LACLAU |
Correspondent | JEAN-PIERRE LACLAU INODENT SUITE 120 CANAL SQUARE 1054 31ST STREET NW WASHINGTON, DC 20007 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-20 |
Decision Date | 1990-04-16 |