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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K152136
Device Name Recovery Cone Removal System
Applicant
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Applicant Contact Joni Creal
Correspondent
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Correspondent Contact Joni Creal
Regulation Number870.5150
Classification Product Code
MMX  
Date Received07/31/2015
Decision Date 02/18/2016
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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