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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K093977
Device Name ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX
Applicant
Chestnut Medical Technologies, Inc.
173 Jefferson Dr.
Menlo Park,  CA  94025
Applicant Contact DANIEL CHER
Correspondent
Chestnut Medical Technologies, Inc.
173 Jefferson Dr.
Menlo Park,  CA  94025
Correspondent Contact DANIEL CHER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/24/2009
Decision Date 04/22/2010
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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