510(k) K041620
K041620 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "NEURA WRAP NERVE PROTECTOR". The FDA issued a decision of Substantially Equivalent on July 16, 2004. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2004
- Date Received
- June 16, 2004
- 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