Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K993801
Device Name GYNECARE LAPAROSCOPIC MORCELLATOR
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
somerville,  NJ  08876 -0151
Applicant Contact gregory r jones
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
somerville,  NJ  08876 -0151
Correspondent Contact gregory r jones
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/09/1999
Decision Date 02/07/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No