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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Blood, Fetal
510(k) Number K891388
Device Name 1570 - FETAL BLOOD SAMPLING KIT
Applicant
Transidyne General Corp.
3711 Plz. Dr., #4
Ann Arbor,  MI  48108
Applicant Contact MARGARET K BEAUDET
Correspondent
Transidyne General Corp.
3711 Plz. Dr., #4
Ann Arbor,  MI  48108
Correspondent Contact MARGARET K BEAUDET
Regulation Number884.1560
Classification Product Code
HGW  
Date Received03/14/1989
Decision Date 03/28/1989
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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