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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K932251
Device Name ROTATOR;MALE-MALE, MALE-FEMALE
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 Number870.4240
Classification Product Code
DTR  
Date Received05/10/1993
Decision Date 08/05/1993
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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