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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 K031485
Device Name RINSPIRATION SYSTEM
Applicant
Kerberos Proximal Solutions
1400 Terra Bella, Suite K
Mountain View,  CA  94043
Applicant Contact TOM MASON
Correspondent
Kerberos Proximal Solutions
1400 Terra Bella, Suite K
Mountain View,  CA  94043
Correspondent Contact TOM MASON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/12/2003
Decision Date 09/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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