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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K960566
Device Name NHMC FOLEY CATHETERIZATION TRAY
Applicant
National Healthcare Mfg. Corp.
251 Saulteaux Crescent
Winnipeg, Mb,  CA R3J 3C7
Applicant Contact BOB JACKSON
Correspondent
National Healthcare Mfg. Corp.
251 Saulteaux Crescent
Winnipeg, Mb,  CA R3J 3C7
Correspondent Contact BOB JACKSON
Regulation Number876.5130
Classification Product Code
FCM  
Date Received02/09/1996
Decision Date 02/29/1996
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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