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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 K031599
Device Name CD LEYCOM PRESSURE/VOLUME CATHETERS
Applicant
Cd Leycom BV
Argonstraat 116
Zoetermeer,  NL 2718 SP
Applicant Contact T. LOPES
Correspondent
Cd Leycom BV
Argonstraat 116
Zoetermeer,  NL 2718 SP
Correspondent Contact T. LOPES
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Codes
DRO   DXO  
Date Received05/21/2003
Decision Date 12/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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