The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Mi Flow (gcuc-450).
| Device ID | K090747 |
| 510k Number | K090747 |
| Device Name: | MI FLOW (GCUC-450) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161323185 | K090747 | 000 |
| 04548161283376 | K090747 | 000 |
| 14548161323116 | K090747 | 000 |
| 14548161323123 | K090747 | 000 |
| 14548161323130 | K090747 | 000 |
| 14548161323147 | K090747 | 000 |
| 14548161323154 | K090747 | 000 |
| 14548161323161 | K090747 | 000 |
| 14548161323178 | K090747 | 000 |
| 04548161283000 | K090747 | 000 |