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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K950835
Device Name SCIMED CHOICE PT PTCA GUIDE WIRE
Applicant
Scimed Life Systems, Inc.
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact DEBORAH L JENSEN
Correspondent
Scimed Life Systems, Inc.
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact DEBORAH L JENSEN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/24/1995
Decision Date 05/25/1995
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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