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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, Diagnostic
510(k) Number K782082
Device Name CATHETER, DIGITAL POSITRAL II
Applicant
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Correspondent
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/14/1978
Decision Date 12/20/1978
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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