PQE · Ostomy Care Kit
Gastroenterology, Urology · 21 CFR 876.5900 · Class 1
Overview
| Product Code | PQE |
|---|---|
| Device Name | Ostomy Care Kit |
| Regulation | 21 CFR 876.5900 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
