510(k) K820490
K820490 is an FDA 510(k) premarket notification submitted by Seamless Hospital Products Co. for the device "IV START TRAY". The FDA issued a decision of Substantially Equivalent on March 16, 1982. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. Seamless Hospital Products Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1982
- Date Received
- February 23, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- I.V. Start Kit
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- SU
- 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.