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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 K982543
Device Name SILVERSTREAK HYDROPHILIC GUIDEWIRE
Applicant
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente,  CA  92673
Applicant Contact TOM DAUGHTERS
Correspondent
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente,  CA  92673
Correspondent Contact TOM DAUGHTERS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/21/1998
Decision Date 12/11/1998
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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