COLONGLIDE LUBRICANT
Device Facts
| Record ID | K141028 |
|---|---|
| Device Name | COLONGLIDE LUBRICANT |
| Applicant | Pediatric Pharmaceuticals, Inc. |
| Product Code | KMJ · General Hospital |
| Decision Date | Jul 24, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6375 |
| Device Class | Class 1 |
Regulatory Classification
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.
