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510(k) K012193

AMC ANTIMICROBIAL PIN/WIRE SLEEVE by Smith & Nephew, Inc. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2002
Date Received
July 12, 2001
Clearance Type
Traditional
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

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