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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K915168
Device Name PROFLEX 5
Applicant
PERIPHERAL SYSTEMS GROUP
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact LINDA GUTHRIE
Correspondent
PERIPHERAL SYSTEMS GROUP
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact LINDA GUTHRIE
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/15/1991
Decision Date 02/19/1992
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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