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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 K003790
Device Name DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
Applicant
DAVOL, INC.
SUBSIDIARY OF C.R. BARD
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact LUCINDA L FOX
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received12/08/2000
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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