510(k) K001466
K001466 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "VOCOM SILICONE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 2000. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2000
- Date Received
- May 10, 2000
- 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