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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, pediatric, for indwelling catheter
510(k) Number K905016
Device Name PEDIATRIC AND INFANT CATH KITS
Applicant
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact LEO BASTA
Correspondent
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent Contact LEO BASTA
Regulation Number876.5250
Classification Product Code
FFH  
Date Received11/07/1990
Decision Date 12/20/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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