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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K897133
Device Name MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
Applicant
Transidyne General Corp.
3711 Plaza Dr., #4
Ann Arbor,  MI  48108
Applicant Contact K BEAUDET
Correspondent
Transidyne General Corp.
3711 Plaza Dr., #4
Ann Arbor,  MI  48108
Correspondent Contact K BEAUDET
Regulation Number868.1100
Classification Product Code
CBT  
Date Received12/27/1989
Decision Date 03/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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