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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K013972
Device Name H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
Applicant
ACKARD LABORATORIES
70 JACKSON DR.
P.O. BOX 1085
CRANFORD,  NJ  07016
Applicant Contact RICHARD HETTENBACH
Correspondent
ACKARD LABORATORIES
70 JACKSON DR.
P.O. BOX 1085
CRANFORD,  NJ  07016
Correspondent Contact RICHARD HETTENBACH
Regulation Number884.4530
Classification Product Code
LKF  
Date Received12/03/2001
Decision Date 12/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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