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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 K934581
Device Name SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
Applicant
Scimed Life Systems, Inc.
2010 E. Center Circle
Plymouth,  MN  55441 -2644
Applicant Contact DEBORAH L JENSEN
Correspondent
Scimed Life Systems, Inc.
2010 E. Center Circle
Plymouth,  MN  55441 -2644
Correspondent Contact DEBORAH L JENSEN
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
DQY  
Date Received09/23/1993
Decision Date 03/31/1994
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
Recalls CDRH Recalls
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