510(k) K152967
K152967 is an FDA 510(k) premarket notification submitted by Toyobo Co., Ltd. for the device "NERBRIDGE". The FDA issued a decision of Substantially Equivalent on Jun 22, 2016. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2016
- Date Received
- Oct 8, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type
- 510(k)