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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K980128
Device Name BALADI INVERTER WITH COAXIAL AORTIC PUNCH
Applicant
CARDIO MEDICAL SOLUTIONS, INC.
17080 NEWHOPE ST.
FOUNTAIN VALLEY,  CA  92708
Applicant Contact THOMAS P SCHROEDER
Correspondent
CARDIO MEDICAL SOLUTIONS, INC.
17080 NEWHOPE ST.
FOUNTAIN VALLEY,  CA  92708
Correspondent Contact THOMAS P SCHROEDER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/14/1998
Decision Date 07/24/1998
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
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