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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K110133
Device Name EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
Applicant
CREGANNA-TACTX MEDICAL
1353 DELL AVENUE
CAMPBELL,  CA  95008
Applicant Contact DENNIS WONG
Correspondent
CREGANNA-TACTX MEDICAL
1353 DELL AVENUE
CAMPBELL,  CA  95008
Correspondent Contact DENNIS WONG
Regulation Number870.5100
Classification Product Code
LOX  
Date Received01/18/2011
Decision Date 06/10/2011
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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