The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Oral Moisturizing Gel.
| Device ID | K101346 |
| 510k Number | K101346 |
| Device Name: | GC ORAL MOISTURIZING GEL |
| Classification | Saliva, Artificial |
| Applicant | GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-13 |
| Decision Date | 2011-01-27 |
| Summary: | summary |