The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Mi Varnish.
Device ID | K102808 |
510k Number | K102808 |
Device Name: | MI VARNISH |
Classification | Varnish, Cavity |
Applicant | GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
Contact | Mark Heiss |
Correspondent | Mark Heiss GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2010-09-28 |
Decision Date | 2010-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00386040004650 | K102808 | 000 |
00386040004636 | K102808 | 000 |
00386040010415 | K102808 | 000 |
00386040010408 | K102808 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MI VARNISH 86318220 4905795 Live/Registered |
GC CORPORATION 2014-06-24 |