510(k) K894455
K894455 is an FDA 510(k) premarket notification submitted by Dept. of the Army for the device "DECONTAMINATING KIT, SKIN: M291". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code MAC (Decontamination Kit), a Class I device regulated under 21 CFR 878.4014. Dept. of the Army has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1989
- Date Received
- July 25, 1989
- 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.