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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K941334
Device Name DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
Applicant
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact JEANNETTE G CLOUTIER
Correspondent
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent Contact JEANNETTE G CLOUTIER
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/18/1994
Decision Date 06/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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