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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, reprocessed
510(k) Number K120204
Device Name REPROCESSED FEMORAL COMPRESSION DEVICE
Original Applicant
STERILMED, INC.
11140 73rd ave. north
maple grove,  MN  55369
Original Contact jason skramsted
Regulation Number870.4450
Classification Product Code
NMF  
Subsequent Product Code
DXC  
Date Received01/23/2012
Decision Date 04/03/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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