510(k) K964011
K964011 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "SUCTION CATHETER TRAY PRODUCT NO. 900277". The FDA issued a decision of Substantially Equivalent (kit) on November 25, 1996. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Customed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 25, 1996
- Date Received
- October 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- General Surgery Tray
- Device Class
- Class II
- Regulation Number
- 878.4370
- 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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