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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 K970492
Device Name INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
Applicant
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Applicant Contact BERNARD ACKERMAN, PH.D.
Correspondent
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Correspondent Contact BERNARD ACKERMAN, PH.D.
Regulation Number884.4530
Classification Product Code
LKF  
Date Received02/10/1997
Decision Date 04/09/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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