510(k) K832126
K832126 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Mpl Division for the device "MICRO Z DISPOS. SPINAL ANESTH. NEEDLE". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Smith & Nephew, Mpl Division has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1983
- Date Received
- July 1, 1983
- 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