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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K043515
Device Name GRAFTSAVER
Applicant
VESCARE, INC.
28 COOK ST.
BILLERICA,  MA  01821
Applicant Contact DAVID WALSH
Correspondent
VESCARE, INC.
28 COOK ST.
BILLERICA,  MA  01821
Correspondent Contact DAVID WALSH
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/20/2004
Decision Date 03/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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