Decontamination Kit
The Decontamination Kit (product code MAC) is a convenience kit containing items used for decontamination procedures in medical settings, established under FDA's 1997 convenience kit guidance and under enforcement discretion, meaning it does not require a 510(k) if it meets all criteria in that guidance. Regulated under 21 CFR 878.4014 and classified as a Class 1 device, it falls under the General and Plastic Surgery specialty with review by the General Hospital (HO) panel. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- MAC
- Device Class
- FDA class 1
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- 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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.