510(k) K120475
K120475 is an FDA 510(k) premarket notification submitted by Shanghai Samedical & Plastic Instruments Co., Ltd. for the device "ANESTHESIA CONDUCTION NEEDLES". The FDA issued a decision of Substantially Equivalent on December 21, 2012. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Shanghai Samedical & Plastic Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2012
- Date Received
- February 16, 2012
- 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