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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K041641
Device Name DAVOL DELIVERY SYSTEM
Applicant
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact SUZANNE LASCALZA
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/17/2004
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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