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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Recording, Electrode, Reprocessed
510(k) Number K153006
Device Name Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
Applicant
Sterilmed, Inc.
5010 Cheshire Pkwy. N.
Suite 2
Plymouth,  MN  55446
Applicant Contact PATRICIA F KAUFMAN
Correspondent
Sterilmed, Inc.
5010 Cheshire Pkwy.
Suite 2
Plymouth,  MN  55446
Correspondent Contact PATRICIA F KAUFMAN
Regulation Number870.1220
Classification Product Code
NLH  
Date Received10/14/2015
Decision Date 06/23/2016
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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