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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K070770
Device Name GORE BALLOON SHEATH
Applicant
W.L. Gore & Associates, Inc.
2647 Lin Gate Court
Pleasanton,  CA  94566
Applicant Contact ALAN CURTIS
Correspondent
W.L. Gore & Associates, Inc.
2647 Lin Gate Court
Pleasanton,  CA  94566
Correspondent Contact ALAN CURTIS
Regulation Number870.4450
Classification Product Code
MJN  
Date Received03/20/2007
Decision Date 06/29/2007
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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