| Device Type ID | 2625 |
| Device Name | Lubricant, 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) Exempt |
| CFR Regulation Number | 880.6375 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KMJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2625 |
| Device | Lubricant, Patient |
| Product Code | KMJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Patient Lubricant. |
| CFR Regulation Number | 880.6375 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PEDIATRIC PHARMACEUTICALS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SION BIOTEXT MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Amerx Health Care Corp. | II | Jul-20-2016 |
| 2 | MEDLINE IND | II | Jan-10-2017 |