510(k) K041453

SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 by Smith & Nephew, Inc. — Product Code DWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2004
Date Received
June 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Vein, External
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type