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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 K101839
Device Name KANEKA PHARMA AMERICA XPRESS-WAY RX
Applicant
KANEKA PHARMA AMERICA LLC
5 WENTWORTH DRIVE
HUDSON,  NH  03051
Applicant Contact RAYMOND KELLY
Correspondent
KANEKA PHARMA AMERICA LLC
5 WENTWORTH DRIVE
HUDSON,  NH  03051
Correspondent Contact RAYMOND KELLY
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received07/01/2010
Decision Date 10/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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