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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 K850677
Device Name TELEFLEX GUIDEWIRE
Applicant
Teleflexmedical, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact HERBERT M CARTER
Correspondent
Teleflexmedical, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact HERBERT M CARTER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/21/1985
Decision Date 09/17/1985
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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