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 |