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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K915678
Device Name MERIT ADMINISTRATION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received12/19/1991
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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