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510(k) K962004

AQ HYDROPHILIC UROLOGICAL CATHETERS by Cook Urological, Inc. — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1996
Date Received
May 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
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  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
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