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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K990705
Device Name MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET
Applicant
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Applicant Contact DENNIS S MADISON
Correspondent
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Correspondent Contact DENNIS S MADISON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/04/1999
Decision Date 06/28/1999
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
Recalls CDRH Recalls
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