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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 K974559
Device Name SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
Applicant
Scimed Life Systems, Inc.
One Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact MELANIE RASKA
Correspondent
Scimed Life Systems, Inc.
One Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact MELANIE RASKA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/05/1997
Decision Date 02/23/1998
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
Recalls CDRH Recalls
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