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510(k) Premarket Notification Database

Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) NumberK904984
Device NameADVANCE 418(TM)
Applicant
PERIPHERAL SYSTEMS GROUP
1395 charleston rd.
mountain view,  CA  94043
Contactjessica ayres
Regulation Number870.1250
Classification Product Code
LIT
Date Received11/02/1990
Decision Date 04/12/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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