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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 K080206
Device Name MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
Applicant
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Applicant Contact HELENE EKSTRAND
Correspondent
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Correspondent Contact HELENE EKSTRAND
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/28/2008
Decision Date 02/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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