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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 K043580
Device Name ALLIGATOR RETRIEVAL DEVICE (ARD)
Applicant
CHESTNUT MEDICAL TECHNOLOGIES, INC.
3583 ROSS ROAD
palo alto,  CA  94303
Applicant Contact anna longwell
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
chalfont,  PA  18914
Correspondent Contact patricia murphy
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/28/2004
Decision Date 03/24/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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