The following data is part of a premarket notification filed by Medactive Oral Pharmaceuticals, Llc. with the FDA for Medactive Oral Gel And Spray.
| Device ID | K152201 |
| 510k Number | K152201 |
| Device Name: | MedActive Oral Gel And Spray |
| Classification | Saliva, Artificial |
| Applicant | MedActive Oral Pharmaceuticals, LLC. 1900 Gunn Highway Odessa, FL 33556 |
| Contact | Brian Walker |
| Correspondent | Brian Walker MedActive Oral Pharmaceuticals, LLC. 1900 Gunn Highway Odessa, FL 33556 |
| 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 | 2015-08-06 |
| Decision Date | 2015-12-30 |