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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Intrauterine Insemination
510(k) Number K940176
Device Name ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
Applicant
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number884.5250
Classification Product Code
MFD  
Date Received01/11/1994
Decision Date 04/23/1996
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
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