510(k) K952227
K952227 is an FDA 510(k) premarket notification submitted by Trebay Medical Corp. for the device "C-FLEX ENDOLYMPHATIC SHUNT". The FDA issued a decision of Substantially Equivalent on June 16, 1995. The device falls under product code ESZ (Tube, Shunt, Endolymphatic), a Class II device regulated under 21 CFR 874.3820. Trebay Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1995
- Date Received
- May 12, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Shunt, Endolymphatic
- Device Class
- Class II
- Regulation Number
- 874.3820
- Review Panel
- EN
- Submission Type