510(k) K991259
K991259 is an FDA 510(k) premarket notification submitted by Te ME NA S.A.R.L. for the device "TE ME NA EPIDURAL CATHETER". The FDA issued a decision of Substantially Equivalent on February 21, 2001. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Te ME NA S.A.R.L. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2001
- Date Received
- April 13, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- AN
- Submission Type