510(k) K983525
K983525 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE REVOX THYROPLASTY IMPLANT". The FDA issued a decision of Substantially Equivalent on December 10, 1998. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1998
- Date Received
- October 8, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Vocal Cord Medialization
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- EN
- Submission Type