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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K913161
Device Name MERIT MANIFOLD
Applicant
MERIT MEDICAL SYSTEMS, INC.
79 WEST 4500 SOUTH
SUITE 9
SALT LAKE CITY,  UT  84107
Applicant Contact DENNIS REIGLE
Correspondent
MERIT MEDICAL SYSTEMS, INC.
79 WEST 4500 SOUTH
SUITE 9
SALT LAKE CITY,  UT  84107
Correspondent Contact DENNIS REIGLE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received07/17/1991
Decision Date 10/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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