510(k) K972383
K972383 is an FDA 510(k) premarket notification submitted by A.Stein - Regulatory Affairs Consulting for the device "EASY-JET DEVICE". The FDA issued a decision of Substantially Equivalent on November 23, 1999. The device falls under product code KLZ (Tube, Shunt, Endolymphatic With Valve), a Class II device regulated under 21 CFR 874.3850. A.Stein - Regulatory Affairs Consulting has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1999
- Date Received
- June 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Shunt, Endolymphatic With Valve
- Device Class
- Class II
- Regulation Number
- 874.3850
- Review Panel
- EN
- Submission Type