ONK · Oral Lubricant
General Hospital · 21 CFR 880.6375 · Class 1
Overview
| Product Code | ONK |
|---|---|
| Device Name | Oral Lubricant |
| Regulation | 21 CFR 880.6375 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Classification Rationale
Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090457 | ORALUBE | Pulpdent Corporation | May 21, 2009 | SESE |
Top Applicants
- Pulpdent Corporation — 1 clearance
