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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 K946180
Device Name SCIMED(R) ENTRE PTCA GUIDE WIRE
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 Number870.1330
Classification Product Code
DQX  
Date Received12/20/1994
Decision Date 03/17/1995
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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