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510(k) K961904

AQ HYDROPHILIC DILATORS by Cook Urological, Inc. — Product Code KOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
May 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

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