510(k) K896800
K896800 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "IRRIGATION TRAY". The FDA issued a decision of Substantially Equivalent (kit) on May 24, 1990. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- May 24, 1990
- Date Received
- December 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Irrigating (Non Dental)
- Device Class
- Class I
- Regulation Number
- 880.6960
- Review Panel
- HO
- Submission Type