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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 K780124
Device Name CATHETERIZATION PROCED. TRAY, URETHRAL
Applicant
WALPAK CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WALPAK CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5130
Classification Product Code
FCM  
Date Received01/24/1978
Decision Date 02/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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