Dressing Change Tray
The Dressing Change Tray is a Class 1 (FDA Class 1) convenience kit assembled for use in wound dressing change procedures in a hospital or clinical setting. Under the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification to market if it meets all criteria in the guidance. The product code is OXQ, with regulation number 880.5075 under the General Hospital medical specialty.
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Basic Information
- Product Code
- OXQ
- Device Class
- FDA class 1
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Review Panel
- SU
- Submission Type
- 7
Device Characteristics
Definition
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.
FEI Numbers
This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.