510(k) K890728
K890728 is an FDA 510(k) premarket notification submitted by Cypress Medical Products, Ltd. for the device "STERILE IRRIGATION TRAYS". The FDA issued a decision of Substantially Equivalent (with conditions) on June 16, 1989. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Cypress Medical Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- June 16, 1989
- Date Received
- February 13, 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