510(k) K023969
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2003
- Date Received
- November 29, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Decontamination Kit
- Device Class
- Class I
- Regulation Number
- 878.4014
- Review Panel
- HO
- Submission Type
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.