The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Initial Mc, Al And Lf.
Device ID | K040567 |
510k Number | K040567 |
Device Name: | GC INITIAL MC, AL AND LF |
Classification | Powder, Porcelain |
Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Contact | Terry L Joritz |
Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-04 |
Decision Date | 2004-04-22 |
Summary: | summary |