510(k) K990366
K990366 is an FDA 510(k) premarket notification submitted by Exmoor Plastics , Ltd. for the device "EXMOOR SUCTION CLEARANCE KIT". The FDA issued a decision of Substantially Equivalent on March 5, 1999. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Exmoor Plastics , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1999
- Date Received
- February 5, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ent Manual Surgical
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type