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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 K842231
Device Name ACKRAD HYSTEROSALPINGOGRAPHY SET
Applicant
Ackrad Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ackrad Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
KNA  
Date Received06/05/1984
Decision Date 09/19/1984
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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