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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K871069
Device Name MODIFIED HYSTEROSALPINGOGRAPY SET
Applicant
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN,PHD
Correspondent
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN,PHD
Regulation Number884.4530
Classification Product Code
KNA  
Date Received03/18/1987
Decision Date 04/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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