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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 K961492
Device Name HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact JEANETTE G CLOUTIER
Correspondent
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact JEANETTE G CLOUTIER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/18/1996
Decision Date 05/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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