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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K984258
Device Name NEUROVASX SUB-MICROINFUSION CATHETER
Applicant
Neuro Vasx, Inc.
2355 Polaris Ln. N.
Suite 116
Plymouth,  MN  55447
Applicant Contact JEFFREY A LEE
Correspondent
Neuro Vasx, Inc.
2355 Polaris Ln. N.
Suite 116
Plymouth,  MN  55447
Correspondent Contact JEFFREY A LEE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/30/1998
Decision Date 02/11/1999
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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