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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 K926479
Device Name BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
Applicant
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact ANNETTE M FAGNANT
Correspondent
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent Contact ANNETTE M FAGNANT
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received12/29/1992
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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