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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 K003020
Device Name CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER
Applicant
CD LEYCOM BV
ARGONSTRAAT 116
ZOETERMEER,  NL 2718 SP
Applicant Contact TIM LENIHAN
Correspondent
CD LEYCOM BV
ARGONSTRAAT 116
ZOETERMEER,  NL 2718 SP
Correspondent Contact TIM LENIHAN
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Codes
DRQ   DXO  
Date Received09/27/2000
Decision Date 05/11/2001
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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