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510(k) K040897

DOVER ROB-NEL CATHETER by Tyco Healthcare — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2004
Date Received
April 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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