510(k) K003443
K003443 is an FDA 510(k) premarket notification submitted by Applied Medical for the device "SUCTION IRRIGATOR". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code FHF (System, Evacuator, Fluid), a Class II device regulated under 21 CFR 876.4370. Applied Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2001
- Date Received
- November 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Evacuator, Fluid
- Device Class
- Class II
- Regulation Number
- 876.4370
- Review Panel
- GU
- Submission Type