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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K090427
Device Name URSA ANGIOGRAPHIC CATHETER
Applicant
Curative Medical Technology, Inc.
102 Mistletoe St.
Lake Jackson,  TX  77566
Applicant Contact AMY MCKINNEY
Correspondent
Curative Medical Technology, Inc.
102 Mistletoe St.
Lake Jackson,  TX  77566
Correspondent Contact AMY MCKINNEY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/19/2009
Decision Date 01/29/2010
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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