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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 K020132
Device Name CHASE CARDIOVASCULAR PATCH KIT
Applicant
CHASE MEDICAL, INC.
1710 FIRMAN DR.
SUITE 100
RICHARDSON,  TX  75081
Applicant Contact DAVE HERNON
Correspondent
CHASE MEDICAL, INC.
1710 FIRMAN DR.
SUITE 100
RICHARDSON,  TX  75081
Correspondent Contact DAVE HERNON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received01/15/2002
Decision Date 02/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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