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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K003467
Device Name CHASE CARDIOVASCULAR PATCH
Applicant
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Applicant Contact DAVE HERNON
Correspondent
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Correspondent Contact DAVE HERNON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received11/08/2000
Decision Date 01/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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