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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 K993288
Device Name SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
Applicant
SULZER CARBOMEDICS, INC.
1300 EAST ANDERSON LN.
AUSTIN,  TX  78752
Applicant Contact EDWARD E NEWTON
Correspondent
SULZER CARBOMEDICS, INC.
1300 EAST ANDERSON LN.
AUSTIN,  TX  78752
Correspondent Contact EDWARD E NEWTON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received10/01/1999
Decision Date 12/29/1999
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
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