VOCOM SILICONE SYSTEM— 510(k) K001466
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K001466 for VOCOM SILICONE SYSTEM, Substantially Equivalent on 2000-07-26. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code MIX
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
Recent devices under product code MIX
view allMore clearances from Smith & Nephew, Inc.
view all- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Data sourced from openFDA. This site is unofficial and independent of the FDA.