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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 K121734
Device Name PLATO MICROCATH 27 MICROCATHETER
Applicant
SCIENTIA VASCULAR , LLC
2700 south 900 west
suite d
salt lake city,  UT  84119
Applicant Contact sharon rockwell
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/13/2012
Decision Date 07/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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