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510(k) K012153

LOWSLEY SUPRAPUBIC TRACTOR by Circon Video — Product Code KOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2001
Date Received
July 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

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