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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K073162
Device Name SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
Applicant
Kensey Nash Corporation
735 Pennsylvania Dr.
Exton,  PA  19341
Applicant Contact ROBIN FATZINGER
Correspondent
Kensey Nash Corporation
735 Pennsylvania Dr.
Exton,  PA  19341
Correspondent Contact ROBIN FATZINGER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/09/2007
Decision Date 02/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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