510(k) K932400
K932400 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on December 13, 1993. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- December 13, 1993
- Date Received
- May 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type