510(k) K183316
K183316 is an FDA 510(k) premarket notification submitted by Dr. Japan Co., Ltd. for the device "Dr J Spinal and Epidural Needles". The FDA issued a decision of Substantially Equivalent on August 12, 2019. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2019
- Date Received
- November 30, 2018
- 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