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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 K921649
Device Name RETRIEVER 10
Original Applicant
47201 lakeview blvd.
p.o. box 5120
freemont,  CA  94538
Original Contact craig j coombs
Regulation Number870.1200
Classification Product Code
Date Received04/06/1992
Decision Date 03/11/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No