MAC

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Decontamination Kit

Device class

Class I (low risk)

Regulation

21 CFR 878.4014

Medical specialty

General, Plastic Surgery

FDA 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.

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