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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K904680
Device Name THERATEK GROUP EXCHANGE CATHETER
Applicant
Dow Corning Wright
14320 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MCGURK BURLESON
Correspondent
Dow Corning Wright
14320 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MCGURK BURLESON
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/15/1990
Decision Date 12/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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