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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K951106
Device Name SILICONE FOLEY CATHETER
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact DARCY JOB
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact DARCY JOB
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
GBM  
Date Received03/10/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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