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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K050130
Device Name KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
Applicant
Kerberos Proximal Solutions, Inc.
10600 N. Tantau Ave.
Cupertino,  CA  95014
Applicant Contact TOM MASON
Correspondent
Kerberos Proximal Solutions, Inc.
10600 N. Tantau Ave.
Cupertino,  CA  95014
Correspondent Contact TOM MASON
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received01/21/2005
Decision Date 05/13/2005
Decision SE - With Limitations (SESU)
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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