The following data is part of a premarket notification filed by Sb Lucius, Inc. with the FDA for Aigis-pt.
Device ID | K024144 |
510k Number | K024144 |
Device Name: | AIGIS-PT |
Classification | Alloy, Gold-based Noble Metal |
Applicant | SB LUCIUS, INC. 9778 KATELLA AVE. STE. 205 Anaheim, CA 92804 |
Contact | Dae-kyu Chang |
Correspondent | Dae-kyu Chang SB LUCIUS, INC. 9778 KATELLA AVE. STE. 205 Anaheim, CA 92804 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-16 |
Decision Date | 2003-03-07 |
Summary: | summary |