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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K781334
Device Name DISPOSABLE SYRINGE FILL TUBE
Applicant
MALLINCKRODT GROUP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT GROUP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/02/1978
Decision Date 08/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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