The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Mi Paste.
Device ID | K042200 |
510k Number | K042200 |
Device Name: | MI PASTE |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
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 | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-13 |
Decision Date | 2004-10-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20386040008706 | K042200 | 000 |
20386040008676 | K042200 | 000 |
20386040008584 | K042200 | 000 |
10386040015233 | K042200 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MI PASTE 77084552 3531617 Live/Registered |
GC Corporation 2007-01-17 |