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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 K120428
Device Name GORE DRYSEAL SHEATH
Applicant
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Applicant Contact NANCY B LOWE
Correspondent
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Correspondent Contact NANCY B LOWE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/13/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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