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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K840703
Device Name SECURE W/30MM DIAM, SHEATH & ADHESIVE
Applicant
WARNE SURGICAL PRODUCTS, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WARNE SURGICAL PRODUCTS, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5250
Classification Product Code
KNX  
Date Received02/17/1984
Decision Date 03/22/1984
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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