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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reprocessed intravascular ultrasound catheter
510(k) Number K110076
Device Name REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369 -5562
Applicant Contact GARRETT AHLBORG
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369 -5562
Correspondent Contact GARRETT AHLBORG
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received01/11/2011
Decision Date 08/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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