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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological (Antimicrobial) And Accessories
510(k) Number K000251
Device Name SPECTRUM SILICONE FOLEY CATHETER
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact BRENDA DAVIS
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact BRENDA DAVIS
Regulation Number876.5130
Classification Product Code
MJC  
Subsequent Product Code
EZL  
Date Received01/27/2000
Decision Date 08/30/2000
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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