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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K081775
Device Name THE MEDCOMP .010 VASCULAR GUIDEWIRES
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact LISA WEIKERT
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact LISA WEIKERT
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/23/2008
Decision Date 03/25/2009
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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