510(k) K022676

ORTHOGUARD AB ANTIMICROBIAL SLEEVE by Smith & Nephew, Inc. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2002
Date Received
August 12, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type