SWANSON TITANIUM CARPAL LUNATE IMPLANT— 510(k) K864491

Name: FDA 510(k) clearance K864491
Creator: U.S. Food and Drug Administration
Published: 1987-04-15

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K864491 for SWANSON TITANIUM CARPAL LUNATE IMPLANT, Substantially Equivalent on 1987-04-15. Applicant: Dow Corning Wright. Device class: 2.

Clearance details

Applicant: Dow Corning Wright
Product code: Code KWN
Device class: Class 2
Regulation: 21 CFR 888.3750
Advisory panel: Orthopedic
Date received: 1986-11-13
Decision date: 1987-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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