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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 K972201
Device Name PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
Applicant
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact EDWARD E NEWTON
Correspondent
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact EDWARD E NEWTON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received06/11/1997
Decision Date 04/14/1998
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
Recalls CDRH Recalls
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