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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K853383
Device Name CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
Applicant
Webster Laboratories, Inc.
5114 Commerce Dr.
Baldwin Park,  CA  91706
Applicant Contact WILTON W WEBSTER
Correspondent
Webster Laboratories, Inc.
5114 Commerce Dr.
Baldwin Park,  CA  91706
Correspondent Contact WILTON W WEBSTER
Regulation Number870.1240
Classification Product Code
DYG  
Date Received08/12/1985
Decision Date 12/03/1985
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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