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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 K875196
Device Name DISPOSABLE CORONARY CONTROL SYRINGE 12CC
Applicant
MERIT MEDICAL SYSTEMS, INC.
P.O. BOX 17484
salt lake city,  UT  84117
Applicant Contact fred lampropoulos
Correspondent
MERIT MEDICAL SYSTEMS, INC.
P.O. BOX 17484
salt lake city,  UT  84117
Correspondent Contact fred lampropoulos
Regulation Number870.1650
Classification Product Code
DXT  
Date Received12/17/1987
Decision Date 02/11/1988
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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