510(k) K964833
K964833 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI DUAL FLUID IRRIGATING SYRINGE". The FDA issued a decision of Substantially Equivalent on February 19, 1997. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Research Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1997
- Date Received
- December 2, 1996
- 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