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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K760641
Device Name MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received09/14/1976
Decision Date 10/08/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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