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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 K934359
Device Name SCIMED STRIKE STEERABLE GUIDE WIRE
Applicant
SCIMED PERIPHERAL INTERVENTIONS
2905 NORTHWEST BLVD., SUITE 60
PLYMOUTH,  MN  55441
Applicant Contact DARLENE A THOMETZ
Correspondent
SCIMED PERIPHERAL INTERVENTIONS
2905 NORTHWEST BLVD., SUITE 60
PLYMOUTH,  MN  55441
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/08/1993
Decision Date 10/07/1993
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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