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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peripheral, atherectomy
510(k) Number K061188
Device Name SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Applicant
FOXHOLLOW TECHNOLOGIES, INC.
740 BAY ROAD
REDWOOD CITY,  CA  94063
Applicant Contact MELISSA S MURPHY
Correspondent
FOXHOLLOW TECHNOLOGIES, INC.
740 BAY ROAD
REDWOOD CITY,  CA  94063
Correspondent Contact MELISSA S MURPHY
Regulation Number870.4875
Classification Product Code
MCW  
Date Received04/28/2006
Decision Date 10/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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