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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K000659
Device Name MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
Applicant
MERIT MEDICAL SYSTEMS, INC.
1111 SOUTH VELASCO
ANGLETON,  TX  77515
Applicant Contact CHESTER MCCOY
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1111 SOUTH VELASCO
ANGLETON,  TX  77515
Correspondent Contact CHESTER MCCOY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/28/2000
Decision Date 03/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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