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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K041464
Device Name BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
Applicant
Busse Hospital Disposables
P.O. Box 11067
Hauppauge,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hospital Disposables
P.O. Box 11067
Hauppauge,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number876.5130
Classification Product Code
EZD  
Date Received06/02/2004
Decision Date 11/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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