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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 K012574
Device Name REPROCESSED FEMORAL COMPRESSION DEVICE
Applicant
STERILMED, INC.
11400 73RD AVE N., SUITE 100
MAPLE GROVE,  MN  55369
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
STERILMED, INC.
11400 73RD AVE N., SUITE 100
MAPLE GROVE,  MN  55369
Correspondent Contact PATRICK FLEISCHHACKER
Regulation Number870.4450
Classification Product Code
NMF  
Date Received08/09/2001
Decision Date 07/18/2002
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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