The following data is part of a premarket notification filed by Sunstar Americas Inc with the FDA for G•u•m Hydral Dry Mouth Oral Gel, G•u•m Hydral Dry Mouth Oral Rinse, G•u•m Hydral Dry Mouth Oral Spray.
| Device ID | K181134 |
| 510k Number | K181134 |
| Device Name: | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray |
| Classification | Saliva, Artificial |
| Applicant | Sunstar Americas Inc 301 E. Central Road Schaumburg, IL 60195 |
| Contact | Liz Bastian |
| Correspondent | Liz Bastian Sunstar Americas Inc 301 E. Central Road Schaumburg, IL 60195 |
| 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 | 2018-04-30 |
| Decision Date | 2018-07-13 |
| Summary: | summary |