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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K122984
Device Name ATLAS GOLD PTA DILATATION CATHETER
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Applicant Contact JENNIFER LOGVIN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received09/26/2012
Decision Date 10/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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