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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 K923480
Device Name SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
Applicant
SCIMED LIFE SYSTEMS, INC.
6655 WEDGWOOD RD.
MAPLE GROVE,  MN  55369
Applicant Contact ANGELA JONES
Correspondent
SCIMED LIFE SYSTEMS, INC.
6655 WEDGWOOD RD.
MAPLE GROVE,  MN  55369
Correspondent Contact ANGELA JONES
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/15/1992
Decision Date 10/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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