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510(k) K915443

URODYNAMIC CATHETER by Cook Urological, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1992
Date Received
December 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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