| Device Type ID | 2684 |
| Device Name | Lubricant, Vaginal, Patient |
| Regulation Description | Patient Lubricant. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6375 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MMS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2684 |
| Device | Lubricant, Vaginal, Patient |
| Product Code | MMS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Patient Lubricant. |
| CFR Regulation Number | 880.6375 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sheffield Pharmaceuticals, LLC | II | Jul-02-2015 |